FDA Pipeline Preview, January 2012 (Alexza Pharmaceuticals, Pfizer, Celladon, Vertex, Avedro)

January 1, 2012

Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride

Recommendations for approval

Fast-track designation

Priority review

First-time generic approval

MInocycline hydrocholride extended-release tablets in 45-mg, 55-mg, 90-mg, and 135-mg strengths (equiv to Solodyn)
LUPIN PHARMACEUTICALS