Content about 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.

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.

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.

PARSIPPANY, N.J. — Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

Watson announced Thursday that it had filed a regulatory approval application with the Food and Drug Administration to market a generic version of Viagra (sildenafil citrate) tablets in 25-mg, 50-mg and 100-mg strengths.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.

Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.

The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for Alzheimer’s disease made by Actavis, the drug maker said Tuesday.

The FDA approved the company’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths, a generic version of Eisai and Pfizer’s Aricept. Donepezil hydrochloride tablets in the two strengths had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

ISSAQUAH, Wash. — Costco Wholesale EVP, CFO and director Richard Galanti told investors during the company’s third quarter 2011 earnings call last week that average prices in pharmacy probably would decline due to the introduction of generic versions of branded drugs.

“[The] only area where you are going to see some average price declines is probably in pharmacy where, and we've all read about it, there is some very well-known branded items that are going to become generic this coming year,” Galanti said.

HAWTHORNE, N.Y. — Taro realized a 21% increase in net sales for its first quarter, the drug maker said.

The company said it raked in net sales of $107.7 million, an increase of $18.7 million. Diluted earnings per share totaled 58 cents, compared with 21 cents in the prior-year period.

Operating income for Taro increased 84.4% to $33.4 million, or 31% of net sales, compared with $18.1 million, or 20.3% of net sales, in 2010.

During the period, Taro received three abbreviated new drug applications from the Food and Drug Administration.

WOONSOCKET, R.I. — Many people who provide care and support to loved ones said they are more likely to be nonadherent to their own personal medication regimen than to neglect providing medications to those they are caring for, according to a new study by researchers at Harvard University, Brigham and Women's Hospital and CVS Caremark. Given this, there's a significant opportunity for pharmacists and doctors to identify and work with caregivers to improve medication adherence and chronic disease management.

PARSIPPANY, N.J. — Watson Pharmaceuticals has acquired Greek drug maker Specifar Pharmaceuticals for $562 million, the two companies said Wednesday.

Watson said that through the acquisition, it had gained a leading generic product development company that develops and out-licenses products throughout the world, while also enhancing its commercial presence in Europe.

NEW YORK — Several states are cutting funding to programs that provide HIV medications to people who can’t afford them in an effort to reduce spending, according to a published report.

The Washington Post reported that more than 8,300 people are on waiting lists to obtain antiretrovirals and other drugs that treat HIV, AIDS and related conditions. The Post article highlighted particularly large program cuts in Illinois and Georgia, as well as one proposed for Florida.