Bradley Pharmaceuticals has announced the launch of Peranex HC Cream (hydrocortisone acetate 2% -- lidocaine HCl 2%) by the company's Kenwood Therapeutics division. Peranex HC Cream is the first product in a new line of anorectal treatments used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area. Each Peranex HC prescription contains 12 full days of therapy with 24 single-use tubes, pre-application wipes, 24 flushable cleansing wipes, and patient information about hemorrhoids.
Following a review of a supplemental New Drug Application, the FDA has approved Sanofi-Aventis’ rapid- acting insulin Apidra (insulin glulisine [rDNA origin] injection) for intravenous administration under proper medical supervision in a clinical setting for glycemic control in adult patients with Type 1 and Type 2 diabetes. The approval provides an additional treatment option for the many hospitalized diabetes patients who may benefit from intravenous insulin therapy in a clinical setting.
The FDA has granted approval of Gilead’s Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension (PAH).
Cephalon announced that it has received approval from the FDA to market Nuvigil (armodafinil) tablets, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder.