The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne. The company expects to launch it in the United States in fourth quarter 2012 under an agreement with Canada-based Cipher Pharmaceuticals.
“Absorica is a critical milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy’s specialized dermatology sales force,” Ranbaxy SVP and regional director for the Americas Venkat Krishnan said.
A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration. Mylan announced the approval of nevirapine tablets in the 200-mg strength. The drug is a generic version of Boehringer Ingelheim’s Viramune. Mylan began shipping the drug immediately after approval. Various versions of the drug had sales of $116.6 million during the 12-month period ended in March, according to IMS Health.
The Food and Drug Administration has approved a new treatment for acne made by a GlaxoSmithKline subsidiary. Stiefel announced the approval of Fabior (tazarotene) foam in the 0.1% strength, calling it the only retinoid in a topical foam for treating acne in patients ages 12 years and older. “Stiefel is dedicated to meeting the needs of patients and dermatologists, and we believe Fabior foam will be an important treatment option for people with moderate to severe acne,” Stiefel VP North America dermatology Jean-Christophe May said.
The Food and Drug Administration has approved a treatment for Type 1 diabetes in children ages 2 to 5 years. Drug maker Novo Nordisk announced the additional approval of Levemir (insulin detemir [rDNA origin]). The insulin already was approved for Type 1 diabetes in older children and adults and Type 2 diabetes in adults, and the drug maker said the new FDA approval made Levemir the only basal insulin analog for use in the 2- to 5-year age group.
Actavis has launched a generic drug for high blood pressure and chest pain, the company said. Actavis announced the launch of nifedipine extended-release tablets in the 90-mg strength, a generic version of Bayer’s Adalat CC. Various versions of the drug had sales of about $23 million in 2011, according to IMS Health.