ABBRIVIATED NEW DRUG PPLICATION

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SEMINAR ON
ABBRIVIATED NEW DRUG PPLICATION (ANDA)
Presented by Nagori Stavan Arunkumar Department
of Pharmaceutics L.M.College of Pharamcy
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Pool of topics
ANDA

1. Introduction
2. History of ANDA
3. Guidelines available for ANDA
4. Filling of ANDA
5. Manufacturing and control requirements of the
   ANDA
6. 180 days exclusitivity under Hatch Waxman
   amendment
7. Concept of Paragraph I to IV
8. Substantially complete ANDA
9. House keeping regulation
10. Patent expiration regulation
11. Triggering period
12. Waivers of exclusitivity
13. 505(b)(2) application
14. Supplemental new drug applications
15. Case studies
16. List of ANDA approved
17. 2006 pending ANDA
18. ANDA filed by or with Indian Pharmaceutical
    company
19. List of references

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1. Introduction
ANDA

• ANDA contains data submitted to FDA's Center for
  Drug evaluation and Research, Office of Generic
  Drugs, for review and ultimate approval of a
  generic drug product.
• Once ANDA is approved, an applicant may
  manufacture and market the generic drug product
  to provide a safe, effective, low cost
  alternative to the American public.
• A generic drug product is the one that is
  comparable to an innovator drug product in dosage
  form, strength, route of administration, quality,
  performance characteristics and intended use.

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ANDA

• All approved products, both innovator and
  generic, are listed in FDA's Approved Drug
  Products with Therapeutic Equivalence Evaluations
  (Orange Book).
• Generic drug applications are termed
  "abbreviated"
• Use of bioequivalence as the base for approving
  generic drug products was established by the
  "Drug Price Competition and Patent Term
  Restoration Act of 1984," also known as the
  WAXMAN-HATCH ACT.

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2. HISTORY OF ANDA
ANDA

• In 1938, proof of safety
• In 1962, THE KEFAUVER HARIS AMENDMENTS
• THE KEFAUVER HARIS AMENDMENTS led to DRUG
  EFFICACY STUDY IMPLEMENTATION (DESI).
• FDAs realization
• Mid 1966 notice in federal Register
• DESI review ultimately led to evolution of ANDA
  concept.

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ANDA

• On April 24th 1970, the ANDA policy was published
  with exception of DESI pending list drugs and
  exempt as per court order
• In November 1984, The Drug Price Competition and
  Patent Term Restoration Act.
• Title 1 ANDA regardless of time before or after
  1962
• Title 2 Patent extension for life lost
• Title 3 Textile and wood products
• In April, 1992 FDA finalized the regulations
  outlining the requirements for ANDAs.

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ANDA

• On November 21, 1997 Modernization Act was
  signed.
• Section 506A-Changes for approved ANDA/NDA
• Hatch-Waxman Amendments

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3. GUIDELINES AVAILABLE FOR ANDA
ANDA

• Guidelines describe format content for the
  following sections.
• Application summary
• Chemistry, Manufacturing and controls section
• Non clinical pharmacology and toxicology section
• Human pharmacokinetics bioavailability section
• Clinical and statically section
• Microbiology section

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ANDA

• Guidelines available for ANDA includes
• Organization of ANDA
• Electronic submission of data for ANDA
• Submission of archival copy of application in
  Microfiche
• Guideline for impurities in drug substances
• Guideline for submitting supporting documentation
  for the Manufacture of Drug substance.
• Guideline for submitting supporting documentation
  for the Manufacture of finished dosage forms.

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ANDA

• Guideline for submitting supporting documentation
  for stability studies of Human drugs and
  Biologics.
• Guideline for packaging
• Guidelines for changes in approved ANDA and NDA
  
• Variations in Drug Products that may be included
  in a single ANDA
• 180 days exclusivity under Hatch Waxman amendment
• Guidelines for alternate source of API in pending
  ANDAs
• Post marketing reporting of Adverse Drug
  reactions
• Guidelines for changes in approved ANDA and NDA
  

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4. FILING OF ANDA
ANDA
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ANDA

• Proper organization
• Proper format, clear table of contents, correct
  folders (jackets), correct tabulation and
  pagination
• Details under 21 CFR 314.50, 21 CFR 314.94 and
  21 CFR 314.440
• OGDs recommendation of bioequivalence, chemistry
  and labeling portions of an application

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Paper based filing of ANDA
ANDA

• Application copies and general format
• Submit Archival (reference, retained and official
  approved copy) and filed copy (duplicate, used by
  FDA investigators) in english
• Translation copy with original reference copy

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ANDA

• Review copy (duplicate, FDA viewer, destroyed) in
  2 sets of binders (jackets)
• In first binder CMC
• In another BE data
• Remaining data (table of contents, labeling) in
  both
• Consistency in color coding binders, volume size
  and specifications, size and quality of paper

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ANDA
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ANDA
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ANDA

• II. Cover letter
• Purpose of submission
• Type of submission (ANDA, amendment, supplement,
  annual report, or resubmission of a previously
  withdrawn application)
• Name, title, address and signature of applicant
• Proprietary name (if any) and name of drug
  product
• Number of volumes submitted
• Commitment to resolution of any issues identified
  in the methods validation process after approval
• Statement that the application or a portion of
  the submission is in electronic process after
  approval
• Clearly identify submissions that contain
  sterility assurance data

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ANDA

• III. Table of content(21 CFR 314509B)

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ANDA
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ANDA

• IV. Tabs
• Contents Section
  Tabs
• E.g. Section VI - Bioavailability/Bioequivalence)
  
• Pagination
• Centre bottom of the page.
• VI. Field copy -additional information
• Foreign applicants should submit the field copy
  to the Office of Generic Drugs

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Electronic submission
ANDA

• ADVANTAGES
• Consistent submission
• Rapid review
• Reduction in archiving and storage space
• Establishment of structured database of technical
  information associated with generic drug
  applications.
• OGD archiving capability
  no guidelines
• OGD has process for some in hard and some in soft
  copy.

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ANDA

• Electronic submissions separated into 2 parts
• To address bioequivalence information
• To address information related to chemistry,
  manufacturing, and controls (CMC)
• Applicant may choose to submit either or both
  parts
• Each part consist three electronic files
• An electronic submission document (ESD)
• A set of data files
• A companion document.

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ANDA

• Key element for entering information in
  electronic submission - Entry and Validation
  Application (EVA).
• First step in submission getting unique 3 digit
  number
• Electronic submission along with hard copy to OGD
• 30 days
• Cover letter-CMC and/or bioequivalence ESD will
  be submitted as electronic version as new
  correspondence within 30 days.

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Difference between submission of NDA and ANDA
NDA requirements ANDA requirements
Well-controlled clinical studies to demonstrate effectiveness Detailed descriptions of the components
Preclinical and clinical data to show safety Manufacturing, controls, packaging, and labeling data sufficient to assure the bioavailability or bioequivalence of the drug to be marketed.
Detailed descriptions of manufacturing and packaging procedures
Proposed annotated labeling referencing all studies from which statement s contained in the package insert has been derived.
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5. MANUFACTURING AND CONTROL
REQUIREMENTS OF THE ANDA-

• Very important
• From 1977-1992, 105 Non approval letter issued by
  FDA

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• FDA Manufacturing and Controls guidelines-
• Guideline for the format and content of an
  application summary.
• Guideline for the format and content of the
  chemistry, manufacturing, and controls section of
  an application.
• Guideline for stability studies for Human drugs
  and Biologics
• Guideline for packaging of Human Drugs and
  Biologics.
• Guideline for submitting supporting
  documentations in drug applications for the
  manufacture of drug substances.
• Guideline for submitting supporting documentation
  for the manufacture of finished dosage forms.
• Guidelines for drug master files.

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ANDA

• Requirements for Drug substances sources
• Copy of potential suppliers most recent
  establishment inspection repot describing FDAs
  findings
• Supplier should have a DMF available at FDA for
  reference purposes
• Specifications for drug substances-
• Assay methodology is not specified into the
  monograph for older drugs or method described is
  not specific FOIs requests to FDA-copy of
  pertinent assay
• Check impurity peaks

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ANDA

• -Drug product requirements-
• Validation studies - to verify the accuracy,
  precision, specificity, recovery and sensitivity
  of the method (s) conducted by the sponsors
  product with those obtained with the original
  brand name product using the same methodology.
• -ANDA expiration dates-
• Tentative approval of two year expiration date
  for a product if satisfactory data reflecting at
  least three months storage under accelerated
  conditions
• Final approval for the expiration date is
  obtained when acceptable shelf life data for two
  years on more than one production lot is made
  available

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6. 180-Day Generic Drug Exclusivity under the
Hatch-Waxman Amendments to the Federal Food,
Drug, and Cosmetic Act
ANDA
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After Hatch-Waxman Amendment resulted into
ANDA

• Increased availability of generics
• 1984 12 prescription were generics
• 2000 44
• 2003 51
• 10,357 FDA approved branded drugs vs. 7,602
  generic counterparts
• Savings of 8 10 billions every year
• Average saving per prescription approximately 53
  
• 1 rise in Generic prescription 1.3 billions
  saving

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ANDA

• 10,357 FDA approved branded drugs vs. 7,602
  generic counterparts
• Savings of 8 10 billions every year
• Average saving per prescription approximately 53
  
• 1 rise in Generic prescription 1.3 billions
  saving

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Generic Pharmaceuticals Facts Figures at a
glance
ANDA

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Generic Pharmaceuticals Facts Figures at a
glance (contd.)
ANDA

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Generic Pharmaceuticals Facts Figures at a
glance (contd.)
ANDA

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7. Concept of paragraph I to IV
ANDA

• For filing ANDA, generic company must include a
  patent certification as per section 505(j) (2)
  (A) (vii) of the Hatch Waxman Act.
• The certificate has to make one of the following
  statements
• No patent information on the drug product that is
  the subject of the ANDA has been submitted to FDA
• That such patent has expired
• The date on which such patent expires
• That such patent is invalid or will not be
  infringed by the manufacture, use, or sale of the
  drug product which the ANDA is submitted.

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ANDA

• The first three paragraphs (I, II, III) results
  in no generic drug being sold during the term of
  the innovators patent protection.
• In case paragraph IV certification generic drugs
  can be sold during the term of the innovators
  patent protection. with rule of 45days suit and
  30 months ban.
• Bann approved unless
• The court decides that such patent is invalid or
  not infringed. In this case ANDA approval is
  made effective on the date of the court decision
• The court decides that such patent has been
  infringed and sets a date for approval of the
  ANDA as provided.
• The court grants a preliminary injuction
  prohibiting the ANDA applicant from engaging in
  the commercial manufacture or sale of the drug
  until the court decides the issues of patent
  validity and infringement.

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8. SUBSTANTIALLY COMPLETE ANDA
ANDA

• Substantially complete means application with
  all required information like bioequivalence,
  etc.
• If a new bioequivalence study required for ANDA
  approval- not substantially complete and the
  applicant would not be eligible for exclusivity.
• Withdrawal of paragraph IV certification
  voluntarily/ settlement/ defeat in patent
  litigation by first applicant-looses
  exclusitivity.
• Again first applicant submit paragraph IV
  certificate for 180 days exclusivity and there
  are no subsequent applicants then first applicant
  would be eligible for exclusivity.

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9. HOUSE KEEPING REGULATIONS
ANDA

• First generic loses patent litigation
  Para IV to III
• 
  (loses exclusivity)
• Same day submission first applicant
• Happens if patent expires on that day or generic
  wants to challenge innovators ANDA for 5 years
  exclusivity and submits at end of 4 year
• For 6 months pediatric exclusitivity happens if
  patent expires on that day or generic wants to
  challenge innovators ANDA for 5(1/2) years
  exclusivity and submits at end of 4(1/2) year

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10. PATENT EXPIRATION REGULATION
ANDA

• Patent for which Para IV filed expires
  first generic loses exclusitivity
• 
  Subsequent generics gets
  exclusitivity

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11. TRIGGER PERIOD
ANDA

• Unnecessary delay or settlement
  Trigger period concept
• Commencement of the 180-day exclusivity period
  for the first applicant is either the first
  commercial marketing of the first applicants
  product, or a decision of a court holding the
  patent invalid, not infringed, or unenforceable,
  whichever is earlier.
• For exercising exclusitivity 180-day
  triggering period
• court decision regarding the patent
  favorable to the first applicant or the first
  applicant must begin commercial marketing of its
  product
• if not first generic would lose its
  eligibility for exclusivity and subsequent
  generic filers for ANDA would be eligible for
  immediate approval.

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ANDA

• There is new triggering period which is
  separate and distinct from the 180-day
  exclusivity period. The triggering period would
  begin upon the
• Tentative approval of a subsequent ANDA with a
  paragraph iv certification for the same drug
  product
• Expiration of a 30 month stay of ANDA approval
  due to patent litigation
• Expiration of a preliminary injunction
  prohibiting marketing of an ANDA product
• Expiration of the statutorily described
  exclusivity periods for the listed drug

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ANDA

• Delay of ANDA into market
• Mean while subsequent generics gets
  tentative approval
• FDA proposes 60 days trigger period for first
  generic to launch product into the market else
  lose exclusitivity

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ANDA

• First generic sued Para IV certification and is
  facing patent litigation by innovator
• Triggering period would not begin at least until
  the 30 month period has lapsed
• At the end of the 30 month period, the triggering
  period would begin on the date a subsequent
  applicant receives tentative approval, or if a
  subsequent applicant had previously received
  tentative approval then on the date the 30 month
  period expired.

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12. WAIVER OF EXCLUSIVITY
ANDA

• No regulations
• Can waive to all subsequent and not single
  generic applicant

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13. 505(b)(2) APPLICATION-
ANDA

• Section 505 of the FDC Act describes 3 types of
  new drug application
• An application that contains full reports of
  investigations of safety and effectiveness
  (Section 505 (b)(1))
• An application that contains full reports of
  investigations of safety and effectiveness but
  where at least some of the information required
  for approval comes from studies not conducted by
  or for the applicant and for which the applicant
  has not obtained a right of reference (Section
  505(b)(2))
• An application that contains information to show
  that the proposed product is identical in active
  ingredient, dosage form, strength, route of
  administration, labeling, quality, performance
  characteristics, and intended use, among other
  things, to a previously approved product (Section
  505(j))

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What kind of information can be used for 505(b)
(2) application?
ANDA

• Published literature
• The FDAs findings of safety and efficacy for a
  previously approved drug product without
  requiring the sponsor to obtain a right of
  reference from the original applicant.

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What kind of application can be submitted as a
505(b) (2) application?
ANDA

• New chemical entity (NCE)/new molecular entity
  (NME)
• Changes to previously approved drugs

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SOME EXAMPLES OF 505(B) (2) APPLICATIONS
ANDA

• Change in dosage form
• Change in route of administration
• Change in strength
• Change in dosage regimen
• Change in formulation (excipient)
• Change in active ingredient like use of different
  salt of same drug
• New molecular entity i.e. is prodrug of
  previously approved drug product
• Substitution of an active ingredient in a
  combination product
• Combination product An application for a new
  combination product in which the active
  ingredients have been previously approved
  individually.
• Rx/OTC switch
• OTC monograph.
• Naturally derived or recombinant active
  ingredient.
• Bioinequivalence

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WHAT CAN'T BE SUBMITTED AS 505(B) (2)
APPLICATIONS?
ANDA

• An application that is a duplicate of a listed
  drug and eligible for approval under section
  505(j).
• An application in which the only difference from
  the reference listed drug is that the extent to
  which the active ingredient(s) is absorbed or
  otherwise made available to the site of action is
  less than the listed drug.
• An application in which the only difference from
  the reference listed drug is that the rate at
  which its active ingredient(s) is absorbed or
  otherwise made available to the site of action is
  unintentionally less than that of the listed drug

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What type of patent and/or exclusivity protection
is a 505(b) (2) application eligible for?
ANDA

• Granted 3 years of Waxman-Hatch exclusivity if
  one or more of the clinical investigations other
  than BA/BE studies was essential to approval of
  the application and was conducted or sponsored by
  the applicant (21 CFR 314.50(j) 314.108(b)(4)
  and (5)).
• Granted 5 years of exclusivity if it is for a new
  chemical entity (21 CFR 314.50(j) 314.108(b)
  (2)).
• Eligible for orphan drug exclusivity (21 CFR
  314.20-316.36) or pediatric exclusivity (section
  505A of the Act).

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BENEFIT OF 505(b) (2) APPLICATION
ANDA

• Filing of ANDA in form of NDA
• 3 or 5 years of Hatch-Waxman marketing
  exclusivity .
• An approved 505(b) (2) product, may receive an
  AB substitutability rating in the Orange Book.

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CURRENT CHALLENGE TO THE 505(b) (2) MECHANISM
ANDA

• 505(b)(2) does to not allow FDA to unauthorizing
  rely on or use of an Innovators proprietary data
  to approve 505(b)(2) NDAs or to give rating A
  in orange book.
• A petition was filed with the FDA on behalf of
  two pharmaceutical industry giants
  (Pfizer/Pharmacia) to curtail the FDAs approval
  of 505(b) (2) applications. The Pfizer/Pharmacia
  petition requested the FDA to
• Cease approval of all 505(b)(2) NDAs
• Refuse to grant A substitutability ratings to
  such products in orange book...

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14. SUPPLEMENTAL NEW DRUG APPLICATIONS
ANDA

• Once an ANDA as an NDA has been approved, any
  significant changes in the conditions described
  in the application must first be approved via a
  supplemental NDA/ANDA.
• Any substantive modifications proposed for the
  formulation may require the submission of
  additional data assuring the bioavailability of
  the drug.
• Certain minor changes, however, as permitted by
  specific regulations, may be made without the
  filing of supplemental applications.

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ANDA

• Supplemental application I is filed for any the
  changes occurs in chemistry, manufacture of drug,
  use, labeling, safety, effectiveness, identity,
  strength, quality or purity of the drug or the
  adequacy of the manufacturing methods,
  facilitation, and controls to preserve these
  elements.

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Supplements to new drug applications requiring
FDA approval before the change is made for the
drug substance.
ANDA

• Relaxation of specification limits
• The establishment of new regulatory limits
• The deletion of a specification or analytical
  method.
• A revision in the method of synthesis, including
  the use of different solvents or alterations in
  the approved route.
• The use of different facility or establishment
  for the drug substances manufacture, where the
  process used to produce the drug substance
  differs materially from that approved in the
  NDA/ANDA and/or the facility has not received a
  current satisfactory, good manufacturing practice
  inspection within the last two years covering the
  manufacturing process.

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Supplements to new drug applications requiring
FDA approval before the change is made for the
drug product.

• The addition or deletion of an ingredient or
  alteration of the composition (except for
  deletion of colorant.)
• The relaxation of specification limits.
• The establishment of a new regulations analytical
  method.
• The deletion of a specification as regulatory
  analytical method.
• A revision in the method of manufacture,
  including changing or relaxing and in process
  control.
• The use of a different facility or establishment,
  including a different of contract, laboratory, on
  labels, to manufacture, process, test, or pack
  the drug.
• The use of new container/closure system or a
  revision of a relevant specification (s) and
  regulatory analytical method(s).
• A change in container size ( except for solid
  forms)
• An extension of the expiration date based on data
  obtained using a new or an unapproved revised
  stability testing protocol.
• The establishment of a new processing procedure
  for batches failing to meet quality assurance
  specifications.
• All labeling changes except for those
  specifically exempted.

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Supplements for changes that may be made before
FDA approval
ANDA

• Full explanation of the basis for the such
  changes is required
• The cover letter and the supplement should be
  plainly marked, Special supplement changes
  being effected.
• Includes for
• The addition of a new specification (s) or test
  method.
• Revisions in methods, facilities( Except for a
  new facility or controls to provide increase
  assurance of product, identity, quality, purity,
  and strength).
• Revisions in labeling to add or strengthen
• A contraindication, warning, precaution or
  adverse reaction.
• An instruction about dosage and administration to
  further assure the safe use of the product.
• A statement about drug abuse, dependence, or over
  dosage.
• Revisions in labeling to delete false, misleading
  , or unsupported indications of use or claims for
  effectiveness.
• Use of a different facilities or establishment to
  manufacture the drug substance, where the method
  of manufacture does not differ materially form
  that in the former facility and the new facility
  has received a satisfactory cGMP inspection
  within the last two year.

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Changes described in the Annual report
ANDA

• Revisions made to comply with an official
  compendium e.g. USP,NF.
• Revisions in the package insert concerning the
  description section, or the how supplied section,
  that do not involve a change in dosage strength
  and / or form, or minor editorial changes in
  these and/or other sections.
• Deletion of a colorant from the drug product.
• Extension of expiration dating based on data
  obtained using a protocol approved in the
  application.
• A switch to another container/closure system,
  where the material (s) used is the same general
  type as previously approved.(e.g. a change from
  one high-density polyethylene to another).
• In the case of solid dosage forms a change in
  container size without a change in the
  container/closure system.
• The deletion or addition of an alternate
  analytical method.

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Supplemental new drug application checklist
ANDA

• Make all submissions in duplicate, including
  cover letters.
• Include a brief description in the cover letter
  of what the supplement contains, including its
  objective and the headings , supplemental
  expedited review requested or special
  supplement changes being effected when
  appropriate.
• Whenever possible make a side by side comparison
  of current versus proposed conditions.
• Use reference numbers for the NDA and the
  supplement if it is an additional submission.
• Describe in detail all aspects of the change
• Use dates when referring to previous submissions
  of FDA letters, particularly if the
  correspondence goes back more than several years.
  
• When submitting photocopies make sure that all
  copies are clear and legible.
• To assure legibility also type the name of the
  person signing the document.
• When referring to drug master files (DMFs),
  confirm that they are up-to-date. Any changes
  submitted to a DMF must be relevant to the
  application (s) they affect.
• Address all submissions concerning supplemental
  NDAs to the appropriate office and division of
  the FDA.

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15. CASE STUDIES
ANDA

• Patent of PAXIL (Paroxetine HCL hemihydrate)
• SmithKline Backhem (SKB) obtained patent of Paxil
  as NDA.
• In 1998 Apotex filed Para IV certificate for
  getting ANDA
• SKB filed legal suit for patent infringement
• 30-months stay on Apotex approval
• SKB filed patent extension 1 for use as liquid
  oral
• 3 more patents in 1999 2000 for anhydrous form
• 5th patent for Paroxetine methanosulfate in 2000
• Serial Patent submission tactics, with newer
  30-month stay every time
• Result The patent of litigation expired, but
  Apotex could not enter due to the newer (later)
  patents

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ANDA

• Patent of BUSPAR (BMS Pharmaceuticals)
• Mylan pharmaceuticals filed Para III ANDA in 98
  (launch after the patent expiry). Got
  Tentative approval from US FDA
• BMS Patent was to expire on 1159 at midnight of
  21st Nov. 00
• Mylan pharmaceuticals loaded the trucks at
  midnight with generic versions of BUSPAR to
  launch in US on 22nd Nov.00
• 12 hours before patent expiry, BMS was granted a
  new patent by US Patent Trademark office
• BMS immediately submitted new patent to US FDA
• FDA updated the orange book and issued letter of
  incompleteness in ANDA to Mylan
• Mylans consignments remained on shipping dock
• In end net result was BMS ruled for 15 years
  without competition from 1986 for Buspar

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16. List of NDA/ANDA approved by FDA from 2004
ANDA
66
ANDA
67
ANDA
68
ANDA
69
ANDA
70
ANDA
71
ANDA
72
ANDA
73
ANDA
74
ANDA
75
ANDA
76
ANDA
77
ANDA
78
ANDA
79
ANDA
80
ANDA
81
ANDA
82
ANDA
83
ANDA
84
ANDA
85
ANDA
86
ANDA
87
ANDA
88
ANDA
89
ANDA
90
ANDA
91
ANDA
92
ANDA
93
ANDA
94
ANDA
95
ANDA
96
ANDA
97
ANDA
98
ANDA
99
ANDA
100
ANDA
101
ANDA
102
ANDA
103
ANDA
104
ANDA
105
ANDA
106
ANDA
107
ANDA
108
ANDA
109
ANDA
110
ANDA
111
ANDA
112
ANDA approved in October 2005
ANDA
113
ANDA
114
ANDA
115
Tentative ANDA approval (July2005)
ANDA
116
ANDA
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17. List of ANDA patents pending this year (from
Jan 2006)
ANDA
Date Filed Docket Name of Petitioner/Subject Matter
02/09/2006 2006P-0070 Pfizer Inc./Misbranding of generic azithromycin products marketed by Teva Pharmaceuticals USA and Sandoz Inc.
02/10/2006 2006P-0072 Olsson,Frank and Weeda, P.C./ANDA for prednisolone sodium phosophate, USP,oral solution, 10 mg prednisolone base/5mL
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18. ANDA filed by or with Indian Pharmaceutical
company
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(No Transcript)
120
Ranbaxys ANDA which are in pipeline for filing
patent
ANDA
121
ANDA
122
ANDA
123
Generics with DR. Reddies Limited
ANDA
Type Name
ANDA Ranitidine tab 75 mg (OTC)
ANDA Ranitidine Cap (150, 300 mg)
ANDA Famotidine tablet (10, 20,40 mg)
ANDA Oxaprozin tablet (600mg)
ANDA Fluxetine Capsule (40mg)
ANDA Enalpril maleate with hydrochlorthiazide tablet (5-12.5,10-25 mg)
ANDA Ibuprofen tablet (400, 600 and 800 mg)
ANDA Ibuprofen tablet (200 mg-OTC)
124
ANDA
Type Name
Tentative ANDA Ciprofloxacin tablet (100, 250, 500, 750 mg)
Tentative ANDA Omeprazole capsule (40mg)
Tentative ANDA Fluxetine tablet (10 mg)
Tentative ANDA Fluxetine Capsule (10, 20 mg)
125
ANDAs with Zydus Cadila
ANDA

• Atenolol tablet
• Methformin HCl
• Promethazine tablet

126
Tentative ANDAs with Zydus cadila
ANDA

• Divalproex Na DR tablet
• Gatifloxain tablet
• Ribavirin capsule and tablet

127
List of generic products available with Cipla
Pharmaceuticals
ANDA
128
19. List of references

• www.fda.gov
• www.phorum.com
• www.morganfinnegan.com
• www.drugdeliverytech.com
• Richard A., Guarino M. D., New drug approval
  process second edition, Marcel dekker, 56,
  325-356/427-446.

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