Generic Drug Market Has Gaps, FDA Tells Firms In Solicitation For ANDAs
US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.
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The Bone, Reproductive and Urologic Drugs Advisory Committee will consider endpoints, clinical trial designs and other issues related to development in the disease.
US agency’s list of off-patent, off-exclusivity drugs that lack generic versions is aimed at improving transparency and encouraging competition, but almost half the 267 listed products involve complex issues that would require further decision-making by FDA ahead of ANDA submission.
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.