A.P. Pharma Puts Off APF530 Launch To 2014 After Another FDA Rejection

A.P. Pharma faces a second commercial setback as FDA issues another “complete response” letter for its long-acting granisetron in chemotherapy-induced nausea and vomiting.

A.P. Pharma is postponing its target launch date for its lead product, APF530, to the first half of 2014 from the second half of 2013, after receiving a “complete response” letter from FDA for prevention of chemotherapy-induced nausea and vomiting (CINV).

Announced on March 28, the “complete response” letter marks another rejection of the candidate, which is a subcutaneously delivered, long-acting...

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