Generics

SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of Syeda (drospirenone and ethinyl estradiol) tablets in the 3-mg/0.03-mg strength.

The drug is a generic version of Bayer HealthCare Pharmaceuticals’ Yasmin. Yasmin and generic versions of the drug had sales of about $365 million during the 12-month period ended in April, according to IMS Health.

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.

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.

PHOENIX — The Healthcare Distribution Management Association on Monday awarded eight leading pharmaceutical and consumer product manufacturers through the presentation of its annual Distribution Industry Awards for Notable Achievements in health care.

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.

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.

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.