FDA approves treatment for vaginal fungus infections
ALLEGAN, Mich. — The Food and Drug Administration has approved a generic treatment made by Perrigo for fungal infections of the vagina, the company said.
Perrigo announced the approval of butoconazole nitrate 2% vaginal cream, a generic version of KV Pharmaceutical’s Gynazole-1, used to treat vulvovaginal candidiasis, an infection caused by Candida fungus. KV voluntarily discontinued selling the drug in January 2009 due to manufacturing problems.
The drug maker said it was the first company to file a complete regulatory application for the drug with the FDA, thus entitling it to 180 days of market exclusivity. Perrigo will launch the drug at the end of the year under a collaboration with KV.
Gynazole had annual sales of $28 million before its voluntary discontinuation, according to Wolters Kluwer Health.
FDA approves Stiefel acne treatment
NEW YORK — 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 th 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.
FDA grants regulatory guidance for nail fungus treatment
SAN DIEGO — Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker’s plans to seek approval for a nail fungus treatment.
Apricus said Tuesday that the FDA granted its request for guidance concerning MycoVa (terbinafine hydrochloride) that will help determine the suitability of the drug’s clinical trial data to support regulatory approval. The drug uses a common treatment for nail fungus, also known as onychomycosis, delivered using the company’s special drug delivery technology.
"This FDA guidance is an integral step in the process of bringing the safe and effective treatment benefits of MycoVa to patients suffering from mild to moderate onychomycosis," Apricus president and CEO Bassam Damaj said. "Extensive clinical trial data and a robust international patent estate firmly support the marketing potential of MycoVa, and we look forward to receiving necessary guidance from the FDA to move the process forward in the U.S."