Dr. Reddy's gets OK for three drugs
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.
Dr. Reddy's also said that the FDA approved its venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths. The drug is a generic version of Effexor XR capsules, a depression and anxiety treatment made by Wyeth, which now is owned by Pfizer.
What's more, the drug maker also said that its letrozole tablets USP in the 2.5-mg strength, a generic version of Novartis' breast cancer drug Femara, will be available in 30-count bottles.
Dr. Reddy's said its abbreviated new drug applications for Aricept and Effexor XR were approved in May, while the company's ANDA for letrozole tablets was approved last week.