Generics

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.

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.

HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.

The FDA said that on Friday it approved versions of Novartis’ drug Femara (letrozole) made by Teva Pharmaceuticals USA, Dr. Reddy’s Labs, Sun Pharmaceutical Industries, Impax Labs, Endo Pharmaceuticals, Roxane Labs, Accord Healthcare, Synthon Pharmaceuticals, Natco Pharma, Indicus Pharma, Fresenius Kabi Oncology and Kudco Ireland.

HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.