Anda

Anda

• 1.
  ANDA (ABBREVIATED NEW DRUG APPLICATION) SWETAYADAV M PHARM EXECUTIVE-CLINICAL RESEARCH
• 2.
  CONTENTS • Introduction • ANDA •Resources for ANDA • Preparation of Drug product for ANDA • ANDA Review Process • Patent Certification & Exclusivity • ANDA Filling
• 3.
  INTRODUCTION USFDA Basics -Protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, nation’s food supply, cosmetics, dietary supplements, and products that give off radiation • Generic Drug - “A drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use • Bioequivalence - In vivo biological equivalence of two drug product. • Bio Waiver - BCS Class I
• 4.
  ANDA (ABBREVIATED NEWDRUG APPLICATION) • Definition: An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Centre for Drug Evaluation and Research, 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 American public
• 5.
   Goals ofANDA • To reduce the Price of Drug • To make available a good quality drug product to US peoples • To reduce the time of development  ANDA Requirement • Same API • Same Route of Administration • Same Dosage form • Same Strength • Same condition of use
• 6.
  RESOURCES FOR ANDA GuidanceDocument • Impurities • cGMP • BA/BE • Packaging Labeling CFR (Code of Federal Regulation) (50 titles) - Codification of the general and permanent rules and regulations - Sec 21 Related to Food & Drug
• 7.
  MAPPs( Manual ofpolicies & procedure) - Official instruction for internal practice and procedure - For better understanding of office policies Laws & Regulation - 1906 Food and Drug Act: - establish regulations of food & drug - 1984 Hatch Waxman Act: - Created abbreviated mechanism for approval of generic copies of all drugs originally approved after 1962 - Preclinical and clinical studies are not require for generics
• 8.
  ANDA forms &Electronic Submission -ANDA Checklist -Form 356 h (Application to market a new drug, biologic or antibiotic drug for human use)
• 9.
  PREPARATION OF DRUGPRODUCT FOR ANDA Basic Need • RLD (Reference Listed Drug) • API (Active Pharmaceutical Ingredient) • Excipients • Packaging Material • Bioequivalence
• 10.
  API (ACTIVE PHARMACEUTICALINGREDIENT) • Same Active ingredient & salt form • Regulated Documents Needed are: - USDMF (Active) - DMF LOA - TSE/BSE Statement - Patent non infringing statement - Polymorphism statement - Outsourcing cGMP - RS & Melamine declaration - MSDS
• 11.
  EXCIPIENTS • Excipients shouldbe the same as close to innovator product • Regulatory Document needed are: - USDMF – TSE/BSE Statement - OVI/RS & Melamine Declaration - MSDS
• 12.
  PACKAGING MATERIAL • Packagingmaterial should be as close to Innovator drug products packing material • Trade Dress Consideration • Regulatory Document Requirement - COA & Specification, DSC Thermo gram, Drawings - Statement of GMP Compliance, 21 CFR Requirement - Latex content statement , TSE/BSE Statement, Food contact declaration - Colorant declaration, USDMF and LOA
• 13.
  BIOEQUIVALENCE • The absenceof a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study • F1 value • F2 value
• 14.
  PATENT CERTIFICATION • ParaI Patent Certification - No Patent with FDA • Para II - Patent is Expired • Para III - Tentative Approval is given final when patent expires • Para IV (Bypass) - Tentative approval final when challenge won
• 15.
  EXCLUSIVITY • 180 DaysExclusivity - FTF - Multiple ANDA on Same Day • Orphan Drug Exclusivity - Orphan drugs are treat rare disease affecting less than 200000 americans - 7 yr - OGD + OOP
• 16.
  ANDA SUBMISSION &FILLINGS • CTD or eCTD format of ANDA (Currently eCTD is more practiced) • Submitted to FDA's Centre for Drug Evaluation and Research, Office of Generic Drugs
• 17.
  Thank you