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FDA Adds 35 New, 22 Revised Product-Specific Guidances for Generic Drugmakers

Posted 08 February 2018 | By Zachary Brennan 

FDA Adds 35 New, 22 Revised Product-Specific Guidances for Generic Drugmakers

The US Food and Drug Administration (FDA) on Thursday unveiled another batch of new and revised product-specific draft guidances on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).

The 35 new and 22 revised guidance documents include what FDA said are 19 guidance documents on complex generics, and add to the 32 new and 19 revised guidance documents issued in October 2017, as well as the 21 new and 16 revised draft guidances released in May 2017 and dozens of others in 2016 and others dating back to 2012.

FDA Commissioner Scott Gottlieb said in a statement: “To date, we’ve now published about 1,600 of these product-specific guidances laying out the path for developing generics to specific products; including more than 350 guidances for developing generics of complex drugs.”

In deciding which guidance documents to issue, FDA’s Office of Generic Drugs (OGD) said in a report that it considers the complexity of the formulation, ability to accurately measure its bioavailability at the site of action, scientific methods to demonstrate bioequivalence and previous experience with and knowledge of similar drugs.

Latest Guidance

New drafts issued Thursday feature specific guidance for generic developers trying to bring competition to market for, among others:
  • Pfizer’s eczema drug Eucrisa (crisaborole), first approved by FDA in December 2016;
  • Tesaro’s PARP inhibitor Zejula (niraparib), approved in March 2017 for females with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy;
  • Clovis Oncology’s PARP therapy Rubraca (rucaparib), approved in December 2016 for advanced ovarian cancer;
  • Exelixis’ Cabometyx (cabozantinib), first approved in April 2016 for the treatment of advanced renal cell carcinoma;
  • Takeda’s multiple myeloma treatment Ninlaro (ixazomib), approved in November 2015.
 Among the revised product-specific drafts is one for oxycodone and one for lansoprazole.

Product-Specific Guidances for Generic Drug Development

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