DRL gets USFDA approval for new drug ANDA

HYDERABAD: Hyderabad based Dr Reddy’s Laboratories (DRL) has received the final approval from the US Food and Drug Administration (USFDA) for another abbreviated new drug application (ANDA).

The ANDA has been granted by the USFDA for zolpidem tartrate tablets. The company can now export this drug in 5 mg and 10 mg dosages to the US. The product is likely to be shipped immediately, the company informed the BSE.

Zolpidem tartrate tablets are the generic version of Sanofi-Aventis' Ambien tablets. In 2006, Ambien tablets recorded sales worth $2.1 billion in the United States. They were sold in the US in the same potency mentioned above, according to IMS Health.

DRL produces finished dosage forms, active pharmaceutical ingredients (APIs) and biotechnology products. It markets and exports its products both in Europe, Russia and the United States apart from India. The Company conducts research in the areas such as diabetes, cardiovascular, anti-infectives, inflammation and cancer.