Regulatory and Washington

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.

PITTSBURGH — A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration.

Mylan announced Wednesday the approval of nevirapine tablets in the 200-mg strength. The drug is a generic version of Boehringer Ingelheim's Viramune. Mylan plans to begin shipping the drug immediately.

Various versions of the drug had sales of $116.6 million during the 12-month period ended in March, according to IMS Health.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Wednesday that, for the second time over the course of one week, it has engaged with a congressional committee to tell the story of community pharmacy’s value in improving patient health and reducing costs, and it has submitted a statement to the U.S. Senate Committee on Finance for the hearing Wednesday titled “Progress in Healthcare Delivery: Innovations from the Field.”

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.

PRINCETON, N.J. — 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 Tuesday 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.

NEW YORK — Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Pertussis, also known as whooping cough, once was among the most feared childhood diseases and was a frequent killer of young children. Today, it's mostly under control, a testament to the importance of vaccinations.

(THE NEWS: Pertussis cases increase tenfold in Washington over May 2011. For the full story, click here )

PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

The company announced that it had filed a regulatory application with the Food and Drug Administration for norethindrone acetate and ethinyl estradiol tablets in the 1-mg/0.01-mg strength and ethinyl estradiol and ferrous fumarate tablets in the 0.01-mg/75-mg strength. The treatment is a generic version of Warner Chilcott's Lo Loestrin Fe.