Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections

 
• By Joseph Haas

Alkermes’ combo pill for schizophrenia and bipolar disorder received an FDA complete response due to manufacturing questions that a physical site review might have resolved.

Hand drawn failure in business. Unfortunate attempt to hit the target
Alkermes gets a complete response letter but it's only CMC issues that are off-target

More from New Products

More from Scrip