Generics

HYDERABAD, India — The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.

PARSIPPANY, N.J. — Watson Pharmaceuticals last week confirmed that the United States Court of Appeals for the Federal Circuit has affirmed the United States District Court for the Southern District of Florida's February 2011 decision that Watson's generic versions of Mucinex, Mucinex D and Mucinex DM extended-release products do not infringe Reckitt Benckiser’s U.S. Patent No. 6,372,252. 

Watson stated it is continuing to seek final approval of the products from the Food and Drug Administration. 

BRIDGEWATER, N.J. — Generic drug maker Amneal has launched three new liquid drugs, the company said Monday.

SHIRLEY, N.Y. — American Regent has launched a generic drug for relieving pressure inside the eye, the company said.

American Regent announced the availability of latanoprost ophthalmic solution in the 0.005% strength.

The drug is a generic version of Pfizer’s Xalatan and is used to treat such conditions as glaucoma and ocular hypertension.

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.

HYDERABAD, India — Dr. Reddy’s Labs has launched a generic drug for treating high blood pressure, the company said Thursday.

Dr. Reddy’s announced the launch of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths.

The drug is a generic version of Novartis’ Lotrel, which had sales of $290 million during the 12-month period ended in March, according to IMS Health.

BALTIMORE — The Food and Drug Administration has approved an additional strength of a generic drug made by Lupin Pharmaceuticals for high blood pressure, Lupin said Wednesday.

Lupin announced the approval of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths. The company already markets the drug in the 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg and 10-mg/20-mg strengths.

WOONSOCKET, R.I. — Preventive health care may be signficiantly less costly than previously thought because of the expanded use of cost-effective generic medications for the treatment and prevention of chronic diseases, according to researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark.