FDA approves Lannett’s ANDA for Hydrochlorothiazide Capsules, 12.5 mg

Lannett Company, Inc. (NYSE AMEX: LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Hydrochlorothiazide Capsules, 12.5 mg. Hydrochlorothiazide Capsules, 12.5 mg, is therapeutically equivalent to the reference listed drug, Microzide® Capsules, 12.5 mg, of Watson Pharmaceuticals. Sales of Hydrochlorothiazide Capsules, 12.5 mg, at Average Wholesale Price (AWP) were approximately $ 204 million for…

Perrigo files ANDA and confirms Astepro Nasal Spray patent challenge

Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, Inc., the owner of the New Drug Application (NDA) of its filing. The ANDA filing involved contributions from both Perrigo and Impax Laboratories, Inc. (Nasdaq: IPXL), who will share costs and benefits of this project.

On…