Pipeline Preview

May 1, 2012

Recent FDA action (through April 2012) related to, Dihydroergotamine, Levadex inhalation aerosol, droxidopa, Northera, Amitriptyline 4% ketamine 2% cream, AmiKet, Afilbercept, ZALTRAP, Nav rAAV8 vector, Carbamazepine, Carbatrol, Vancomycin hydrochloride, Vancocin, Irbesartan, irbesartan-hydrochloriderothiazide, Avapro, Avalide, Fluvastatin, Lescol

Complete response

Fast-track designation

Priority review

First-time generic approvals

Carbamazepine extended-release capsules in 100-mg, 200-mg, and 300-mg strengths (equiv to Carbatrol)
PRASCO LABORATORIES

Vancomycin hydrochloride, USP Capsules (equiv to Vancocin)
VIROPHARMA

Irbesartan and irbesartan-hydrochlorothiazide tablets (equiv to Avapro and Avalide tablets)
TEVA

Fluvastatin capules USP, 20-mg and 40-mg strengths (equiv to Lescol)
MYLAN