Nonexclusive Drugs: FDA Releases 74 Product-Specific Guidances

As a major aspect of its push to build nonexclusive challenge, the US Food and Drug Administration (FDA) on Friday distributed 74 item explicit directions, including 22 new and 52 overhauled directions.

Four of the new draft directions and 45 of the changed directions are for complex medication items, including 16 items for which there are at present no endorsed abridged new medication applications (ANDAs).

Among the new item explicit directions is help for organizations hoping to create conventional forms of AstraZeneca's mantle cell lymphoma treatment Calquence (acalabrutinib), Vertex's cystic fibrosis treatment Symdeko (tezacaftor and ivacaftor) and the stimulant isocarboxazid, among others.

Reexamined directions incorporate data on those creating generics for Otsuka's state of mind issue sedate Abilify (aripiprazole), Novartis' malignant growth treatment Zykadia (ceritinib) and the antipsychotic haloperidol, among others.

"Most of the corrections to these directions give proposals on information gauges organizing for clinical endpoint bioequivalence concentrates to line up with Clinical Interchange Standards Consortium benchmarks," FDA said.

With this most recent cluster of direction, FDA has now issued in excess of 1,650 item explicit directions since 2007.

The office is looking for input to the docket that it says it will consider before settling the item explicit directions.