Regulatory and Washington

PITTSBURGH — Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

Mylan said that its subsidiary, Matrix Labs, has received final approval from the Food and Drug Administration to manufacture and market donepezil hydrochloride tablets in 5-mg and 10-mg strengths. The drug, a generic version of Pfizer and Eisai's Aricept, is used to treat dementia associated with Alzheimer's disease. Mylan said it will launch the product immediately.

HOLLYWOOD, Fla. — Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.

The product — a bottle containing six blue-colored capsules per package — was distributed throughout the United States, Puerto Rico and Canada to Internet and retail consumers, the company reported.

Global Wellness is recalling only lots 809013 and 806030; the recall does not affect sales and distribution of Slim Extreme Gold and Gelslim, the company stated.

HORSHAM, Pa. — The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.

Topaz is seeking approval for ivermectin topical cream, for treating head lice in children and adults.

SILVER SPRING, Md. — The Food and Drug Administration reported Tuesday that U.S. marshals seized probiotic products from UAS Labs that were being marketed as drugs.

MORRISTOWN, N.J. — The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

The FDA approved the company’s zolpidem tartrate extended-release tablets in the 12.5-mg strength. The drug, which is a Schedule IV controlled substance, is a generic version of Sanofi’s Ambien CR. Actavis was the first company to launch a generic version of the drug in the 6.25-mg strength in October 2010.

PHILADELPHIA — Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

The FDA said it revised its PDUFA goal date of June 23 for Lannett's new drug application for morphine sulfate oral solution.

"With a revised PDUFA date in 17 days, we are preparing for the relaunch of our morphine sulfate oral solution product, if approved,” Lannett president and CEO Arthur Bedrosian said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the company said Tuesday.

Watson announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.09-mg/0.02-mg strength.

The drug is a generic version of Pfizer’s Lybrel, which had sales of slightly less than $12 million during the 12-month period that ended in April, according to IMS Health.

HYDERABAD, India — Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

The drug maker said that the FDA approved donepezil hydrochloride tablets, a generic version of Pfizer and Eisai's Arciept, in the 5-mg and 10-mg strengths for the treatment of Alzheimer's disease. Both strengths will be available in 30-, 90- and 500-count bottles.