USA – Generic Drugs: FDA Releases 74 Product-Specific Guidances

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…