Regulatory and Washington

NEW YORK — In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

DUBLIN — Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.

The drug maker announced that it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Acanya (clindamycin phosphate; benzoyl peroxide) gel in the 1.2%/2.5% strength. Acanya is made by Valeant Pharmaceuticals International and Dow Pharmaceutical Sciences and is used to treat acne vulgaris in patients aged 12 and older.

NEW YORK — Generic drug maker Amneal Pharmaceuticals is seeking Food and Drug Administration approval for a gout drug, prompting a lawsuit from the maker of the branded version, according to published reports.

Law360 reported that Takeda Pharmaceuticals USA had sued Amneal in the U.S. District Court for the District of Delaware over the drug Colcrys (colchicine), used to treat gout and familial Mediterranean fever.

SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

WASHINGTON — The last six drug take-back days sponsored by the Drug Enforcement Agency have collected nearly 2.8 million pounds of prescription drugs at more than 5,800 sites across the country, drawing praise from a drug industry trade organization.

The Generic Pharmaceutical Association said it "strongly supports" the DEA's efforts, including the seventh annual National Prescription Drug Take-Back Day, which took place Saturday.

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

The FDA announced the approval of Zohydro ER (hydrocodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term treatment. The agency said the drug was the first extended-release hydrocodone product not combined with another drug, such as acetaminophen, to be approved by the agency.

SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.