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ANDA Filling Process
The document discusses generic drugs and the Abbreviated New Drug Application (ANDA) process. It explains that an ANDA contains data to review and approve a generic drug as a safe and effective alternative to the original brand name drug. It provides details on the Hatch-Waxman Act which established the modern generic drug approval pathway and allows generics to reference clinical data from the branded version. The document also outlines the requirements for generic drugs to be approved as well as the various certification pathways in the ANDA process.
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ANDA Filling Process
- 1. VIPIN ADLAK REGULATORY AFFAIRS BHARATPARENTERALS LTD, VADODARA
- 2. An Abbreviated NewDrug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange ANDA 2
- 3. INNOVATOR VS GENERICS S.N.PARAMETERS INNOVATOR DRUG GENERIC DRUG 1. Active ingredients Same Same 2. Safety & efficacy Same Same 3. Quality & strength Same Same 4. Performance and standards Same Same 5. Costs/prescription Highly expensive Less expensive 6. FDA inspection of manufacturing facilities Yes Yes 7. FDA reviews reports of adverse reactions Yes Yes 8. FDA reviews drug labeling Yes No 9. Extensive research and 3
- 4. Generic Drug Approval In 1970 FDA established the ANDA as a mechanism for the review and approval of generic versions. Before 1978, generic product applicants were required to submit complete safety and efficacy through clinical trials. Post 1978, applicants were required to submit published reports of such trials documenting safety and efficacy. Neither of these approaches was considered satisfactory and so originated Hatch Waxman Act on 1984. 4
- 5. Indispensability Grounds For Generics Containthe same active ingredients as the innovator drug (inactive ingredients may vary). Must be identical in strength, dosage form, and route of administration. Must have same use/indications. Must be bioequivalent. Must have same batch requirements for Identity, Safety & Purity. 5
- 6. Commonly known as“Drug Price Competition & Patent Term Restoration Act” of 1984. “The Hatch-Waxman Act is an act dealing with the approval of generic drugs and associated conditions for getting their approval from FDA, market exclusivity, rights of exclusivity, patent term extension and Orange Book Listing.”Necessitated By : 1. Absence of Generic drug manufacturing. 2. Cumbersome regulatory procedures. 3. Patients were denied the option of cheaper drugs. Hatch-Waxman Act 6
- 7. 1. Maintaining listof patents which would be infringed. 2. Only Bioavailability studies and not clinical trials needed for approval. 3. Para I, II, III and IV certifications. 4. Data exclusivity period for New Molecular Entities. 5. Extension of the original patent term. 6. The “Bolar” Provision. General Provisions of the Act 7
- 8. Recent additions tothe Hatch-Waxman Act Under the “Medicare Prescription Drug and Modernization Act”, 2003: 1.Non-extension of the 30-month period. 2.Time limit for informing patent owner. 3.Provision for allowing declaratory judgment. 4.Benefit of exclusivity for several ANDAs filed on same day allowed. 8
- 9. ANDA CERTIFICATION CLAUSES PARAGR APH I PARAGR APHII PARAGR APH III PARAGR APH IV 9
- 10. PARA-I Required patent information has notbeen filed. FDA may approve generics immediately, one or more applicants may enter. PARA-II Patent has expired FDA may approve generics immediately, one or more applicants may enter. 10
- 11. PARA-III Patent not expired, willbe expired on a specific date. FDA may approved ANDA effective on the date of expiration, one or more applicant may enter. PARA-IV Patent is invalid or non infringed by generic applicant. Generic applicant file notice to patent holder. 11
- 12. PARA IV CERTTIFICATION After 45days Patent Holder doesn’t sue applicant ► FDA may approve ANDA. ANDA Applicant granted approval. After 45 days Patent Holder sues the Applicant ► 30months stay granted to Patent Holder. 30 Months stay expired For the first Applicant the EMR of 180 days starts with court’s decision. Subsequent approvals for EMRs are granted after expiry of first applicant’s 180 days. 30 Months stay not expired. 12
- 13. 30 Months staynot expired If judgement’s in favour of Patent Holder ► FDA can not approve ANDA untill patent expiry. No entry occurs untill Patent Expiry. Judgement favouring ANDA ► EMR of 180 days begins for first applicant. First Applicant enters, subsequent applicants enter only after expiry of EMR for the First Applicant. 13
- 14. APPLICANT ANDA ACCEPTABLE & COMPLETE REFUSE TOFILE- LETTER ISSUED B.E. REVIEW REQUEST FOR PLANT INSPECTION CHEMISTRY/MICRO REVIEW LABELING REVIEW NOT APPLICABLE LETTER ANDA APPROVED B.E. DEFICIENCY LETTER APPROVAL DEFERRED PENDING SATISFACTORY RESULTS PREAPPROVAL INSPECTION ACCEPTENCE B.E. REVIEW ACCEPTABLE CHEMISTRY/LABELING REVIEW ACCEPTABLE YES YES YES NO NO NO NO ANDA REVIEW PROCESS 14
- 15. MODULE 1 MODULE 3MODULE 4 MODULE 5 Regional Admin. Information Quality Overall summa ry Non Clinical overviewNon Clinical Summary Clinica l Overvi ew Clinical Summary Quality Non Clinical Report Clinical Report The CTD Triangle 15
- 16. MODULES IN ACTD MODULE I: Administrative and Prescribing Information 1.Table of Contents. 2.Includes data of Administrative Documents entailing: Patent Information on patented product. Patent Certifications. Debarment certification. 3. Prescribing information like Package and container labels, packaging inserts, patient leaflets, etc. 4. Labelling Comparison between Innovator and Generic drug. 16
- 17. MODULE II: SUMMARIESAND OVERVIEWS 1. Table of Contents. 2. Introduction to Summary Documents. 3. Overviews and Summaries: Module II should contain documents like: M4Q: The CTD- quality M4S: The CTD- safety M4E: The CTD- efficacyMODULE III: information on product quality 1. Table of Content. 2. Body of Data. 3. Literature Reference. 17
- 18. MODULE IV: NONCLINICAL STUDY REPORTS Not required in ANDA Filing. MODULE V: CLINICAL STUDY REPORTS 1. Table of Contents. 2. Study Reports including Case Report Forms and Case Report Tabulations. 18
- 19. RECOMMENDATIONS FOR e-CTD 1.PDF Files with version 3.0 of Acrobat Reader 2. Use of Embedded fonts in the Portable Document Format 3. A Print area of 8.5 inches by 11 inches and margin of 1 inches is ensured on sides. 4. Scanned Documents should be avoided as Source Documents. 5. Hypertexts can be indicated by Blue-Texts or by rectangles using thin lines. 19
- 20. 6. Numbering onthe PDF and Documents should be included as same. 7. Security or Passwords should not be included. 8. Full Indexes should be included. 9. Electronic Signatures may be added, Procedures are being employed for archival of the same. 20
- 21. BIOEQUIVALENCE A Generic drugis considered to be bioequivalent to Brand drug if: Rate & extent of absorption do not show a significant difference from RLD. Two drugs are said to be Bioequivalent if their Bioavailability after administration in same dose are similar to a degree that there effects, with respect to safety & efficacy can be expected to be the same. 21
- 22. NDA REQUIREMENT ANDA REQUIREMENT NDAVs ANDA Review Process 22
- 23. First-Time Generic Drug Approvals- July 2011 Generic Drug Name Generic Manufacturer Brand Name Approval Date FONDAPARINUX SODIUM INJECTION DR. REDDY'S LABORATORIE S LIMITED ARIXTRA INJECTION 7/11/2011 ALFUZOSIN HYDROCHLORI DE EXTENDED- RELEASE TABLETS TEVA PHARMACEUTI CALS USA UROXATRAL EXTENDED- RELEASE TABLETS 7/18/2011 ALFUZOSIN HYDROCHLORI DE EXTENDED- RELEASE TABLETS SUN PHARMA GLOBAL FZE UROXATRAL EXTENDED- RELEASE TABLETS 7/18/2011 PARICALCITOL SANDOZ ZEMPLAR 7/27/2011 23
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Editor's Notes
- #3 Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.