ANDA filing
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ANDA filing

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The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed ...

The presentation aims at a students focussed perspective of Abbreviated New Drug Application filing with premier regulatory body like USFDA, the eCTD is followed worldwide for drug submission aimed for gaining particular market approvals.When submitted with FDA it is evaluated by CDER. eCTD is further a mandatory submission for ANDAs with FDA and for NDAs with EU and Japan.

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  • 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. 

ANDA filing ANDA filing Presentation Transcript

  • By: DEBANGSHU S. ROY MBA P.M. Hamdard University
  • ANDAAn Abbreviated New Drug Application (ANDA) contains data which whensubmitted to FDAs CDER, Office of Generic Drugs, provides for the reviewand ultimate approval of a generic drug product.Once approved, an applicant may manufacture and market the genericdrug product to provide a safe, effective, low cost alternative to thepublic. All approved products, both innovator and generic, are listed inFDAs Approved Drug Products with Therapeutic EquivalenceEvaluations (Orange Book). 2
  • INNOVATOR VS GENERICSS.N. PARAMETERS INNOVATOR DRUG GENERIC DRUG1. Active ingredients Same Same2. Safety & efficacy Same Same3. Quality & strength Same Same4. Performance and standards Same Same5. Costs/prescription Highly expensive Less expensive6. FDA inspection of manufacturing facilities Yes Yes7. FDA reviews reports of adverse reactions Yes Yes8. FDA reviews drug labeling Yes No9. Extensive research and development investments Yes No10. Expensive marketing & advertising Yes No11. Patent protection Yes No12. FDA review to show active ingredient is equivalent to original NA Yes13. Product Development Time ~ 12 yrs 2- 4 yrs 3
  • Generic Drug Approval In 1970 FDA established the ANDA as a mechanism for the review andapproval of generic versions. Before 1978, generic product applicants were required to submit completesafety and efficacy through clinical trials. Post 1978, applicants were required to submit published reports of suchtrials documenting safety and efficacy.Neither of these approaches was considered satisfactory and so originatedHatch Waxman Act on 1984. 4
  • Indispensability Grounds For GenericsContain the same active ingredients as the innovator drug (inactive ingredientsmay 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.Must follow strict standards of FDAs GMPs. 5
  • Hatch-Waxman Act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 drugsand associated conditions for getting their approval from FDA, marketexclusivity, 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. 6
  • General Provisions of the Act1. Maintaining list of 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. 7
  • Recent additions to the Hatch-Waxman ActUnder 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
  • ANDA CERTIFICATION CLAUSES PARAGRAPH PARAGRAPHPARAGRAPH I PARAGRAPH IV II III 9
  • PARA-I PARA-II Required patent information has not Patent has expired been filed. FDA may approve FDA may approvegenerics immediately, generics immediately, one or more one or moreapplicants may enter. applicants may enter. 10
  • PARA-III PARA-IVPatent not expired, will Patent is invalid or nonbe expired on a specific infringed by generic date. applicant.FDA may approved ANDA effective on the date of Generic applicant fileexpiration, one or more notice to patent holder. applicant may enter. 11
  • PARA IV CERTTIFICATION After 45 days PatentAfter 45 days Patent Holder sues the Holder doesn’t sue Applicant 30monthsapplicant FDA may stay granted to Patent approve ANDA. Holder.ANDA Applicant granted 30 Months stay expired 30 Months stay not approval. expired. For the first Applicant Subsequent approvals the EMR of 180 days for EMRs are granted starts with court’s after expiry of first decision. applicant’s 180 days. 12
  • 30 Months stay not expiredIf judgement’s in favour Judgement favouringof Patent Holder FDA ANDA EMR of 180 can not approve ANDA days begins for first untill patent expiry. applicant. First Applicant enters, subsequent applicants No entry occurs untill enter only after expiry of Patent Expiry. EMR for the First Applicant. 13
  • ANDA REVIEW PROCESS APPLICANT ANDA ACCEPTABLE & REFUSE TO FILE- COMPLETE NO LETTER ISSUED YES B.E. REVIEW CHEMISTRY/MICRO REVIEW REQUEST FOR PLANT INSPECTION LABELING REVIEW CHEMISTRY/LABELING B.E. REVIEW ACCEPTABLE YES REVIEW ACCEPTABLE NO NO PREAPPROVAL INSPECTION NOT APPLICABLE ACCEPTENCE NO LETTERB.E. DEFICIENCY LETTER YES APPROVAL DEFERRED PENDING SATISFACTORY RESULTS ANDA APPROVED 14
  • The CTD Triangle Regional Admin. Information MODULE 1 Non Clinical Clinical Quality overview Overview Overall Non Clinical Clinical summary Summary Summary Quality Non Clinical Clinical Report ReportMODULE 3 MODULE 4 MODULE 5 15
  • MODULES IN A CTDMODULE I: Administrative and Prescribing Information1.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
  • MODULE II: SUMMARIES AND OVERVIEWS1. 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
  • MODULE IV: NON CLINICAL STUDY REPORTSNot required in ANDA Filing.MODULE V: CLINICAL STUDY REPORTS1. Table of Contents.2. Study Reports including Case Report Forms and Case Report Tabulations. 18
  • RECOMMENDATIONS FOR e-CTD1. PDF Files with version 3.0 of Acrobat Reader2. Use of Embedded fonts in the Portable Document Format3. 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
  • 6. Numbering on the 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 forarchival of the same. 20
  • BIOEQUIVALENCEA Generic drug is 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 afteradministration in same dose are similar to a degree that there effects, withrespect to safety & efficacy can be expected to be the same. 21
  • NDA Vs ANDA Review ProcessNDA REQUIREMENT ANDA REQUIREMENT 22
  • First-Time Generic Drug Approvals - July 2011Generic Drug Generic Brand Name Approval DateName ManufacturerFONDAPARINUX SODIUM DR. REDDYS ARIXTRA INJECTION 7/11/2011INJECTION LABORATORIES LIMITEDALFUZOSIN TEVA UROXATRAL EXTENDED- 7/18/2011HYDROCHLORIDE PHARMACEUTICALS USA RELEASE TABLETSEXTENDED-RELEASETABLETSALFUZOSIN SUN PHARMA GLOBAL UROXATRAL EXTENDED- 7/18/2011HYDROCHLORIDE FZE RELEASE TABLETSEXTENDED-RELEASETABLETSPARICALCITOL SANDOZ CANADA, INC. ZEMPLAR INJECTION 7/27/2011INJECTIONMETRONIDAZOLE GEL TOLMAR INC. METROGEL 7/22/2011 23
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  • THANK YOU 40