BioCentury
ARTICLE | Regulation

Alkermes expects quick resolution to FDA setback for antipsychotic

November 17, 2020 10:34 PM UTC

Alkermes expects a swift resolution to a manufacturing issue that led to FDA’s issuance of a complete response letter for ALKS 3831, but the company isn’t yet committing to a launch timeline for the antipsychotic combination therapy.

Alkermes plc (NASDAQ:ALKS) SVP of Regulatory Affairs Heather Faulds said on a conference call Tuesday that FDA’s remote review of records provoked concerns that the coating on some ALKS 3831 tablets could result in erosion. Due to ongoing concerns about the COVID-19 pandemic, the agency was not able to conduct a pre-approval inspection at an Ohio facility where the therapy is manufactured...

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