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GlaxoSmithKline (GSK) announced that the FDA has issued an approvable letter for its topical antibacterial, Altabax (retapamulin ointment), 1 percent, for the treatment of secondarily infected traumatic lesions (SITL).
The FDA issued an approvable letter for Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) Pennsaid to treat osteoarthritis of the knee, the company announced.
New River Pharmaceuticals and its collaborative partner Shire announced that FDA has issued a second approvable letter for Vyvanse (lisdexamfetamine dimesylate, formerly known as NRP104) for the treatment of attention-deficit/hyperactivity disorder (ADHD).
Antares Pharma announced that its development partner BioSante Pharmaceuticals has initiated a Phase III safety and efficacy trial of Antares' transdermal testosterone gel, LibiGel, for the treatment of female sexual dysfunction (FSD).
Biomira announced that its global Phase III clinical trial, START, assessing the efficacy and safety of Stimuvax (BLP25 liposome vaccine) as a potential treatment for patients with unresectable, stage III, non-small-cell lung cancer (NSCLC) is open for patient enrollment.
Barr Laboratories, a subsidiary of Barr Pharmaceuticals, Dec. 26 confirmed that it is seeking approval from the FDA to manufacture and market a generic version of Celgene Corporation's Thalomid
capsules, 50 mg and 100 mg.
Adams Respiratory Therapeutics Dec. 27 announced that it has submitted a new drug application (NDA) to the FDA for 600-mg and 1200-mg oral solid extended-release guaifenesin combination products for the treatment of cough.