A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines

  • Saffiya Khatun M Department of pharmaceutical regulatory affairs, Krishna Teja Pharmacy College, Tirupati, India
  • Jyothshna Devi Katamreddy Department of pharmaceutical regulatory affairs, Krishna Teja Pharmacy College, Tirupati, India
  • Jayachandra Reddy P

Abstract

USFDA is one the most regulated agencies wherein the submission process is most critical. The study depends on how to submit ANDA application as per FDA, CDER guidelines in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD&C Act). No drug would be available in the market until and unless it get approved by Regulatory Authorities. “Paragraph IV Certification” is useful for exclusive right to market the generic drug for 180 days. Submission is for the company which is seeking to copy branded drug before expiration of patents to get benefit over it, a generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards established by FDA in RLD (Reference listed drug). This study covers the introduction of ANDA submission to FDA and ACT related to the submission in to paragraph IV and the details of ANDA filling in the eCTD format and overview of review process the checklist to the applicant.

Keywords: Orange Book, Paragraph IV, Certification, Submission, Generics, CDER, ANDA, USFDA, NDA.

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