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Wednesday, July 28, 2010

Lannett : FDA Approval For Phentermine Hydrochloride Capsules USP 30 MG...

LannettJuly 20, 2010 – Lannett Company, Inc. (NYSE AMEX: LCI) announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Phentermine Hydrochloride Blue/White Seed Capsules USP, 30 mg, the generic equivalent of Sandoz, Inc.’s Reference Listed Drug (RLD) Phentermine Hydrochloride Capsules USP, 30 mg. According to Wolters Kluwer, U.S. sales of Phentermine Hydrochloride Capsules USP, 30 mg in 2009 were approximately $36.5 million at Average Wholesale Price (AWP). This does not include sales of Phentermine made directly to consumers through clinics.
Phentermine Hydrochloride is indicated as a short-term adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index... [PDF] Lannett's Press Release -