Generic Drugs: FDA Releases 74 Product-Specific Guidances

Regulatory NewsRegulatory News | 22 February 2019 |  By 

As part of its push to increase generic competition, the US Food and Drug Administration (FDA) on Friday published 74 product-specific guidances, including 22 new and 52 revised guidances.
Four of the new draft guidances and 45 of the revised guidances are for complex drug products, including 16 products for which there are currently no approved abbreviated new drug applications (ANDAs).
Among the new product-specific guidances is help for companies looking to develop generic versions of AstraZeneca’s mantle cell lymphoma treatment Calquence (acalabrutinib), Vertex’s cystic fibrosis treatment Symdeko (tezacaftor and ivacaftor) and the antidepressant isocarboxazid, among others.
Revised guidances include information on those developing generics for Otsuka’s mood disorder drug Abilify (aripiprazole), Novartis’ cancer treatment Zykadia (ceritinib) and the antipsychotic haloperidol, among others.
“The majority of the revisions to these guidances provide recommendations on data standards formatting for clinical endpoint bioequivalence studies to align with Clinical Interchange Standards Consortium standards,” FDA said.
With this latest batch of guidance, FDA has now issued more than 1,650 product-specific guidances since 2007.
The agency is seeking feedback to the docket that it says it will consider before finalizing the product-specific guidances.

Product-Specific Guidances for Generic Drug Development


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