Taro Pharmaceutical Industries Ltd. (NASDAQ: TARO) yesterday reported that its U.S. affiliate has received approvals from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Applications ("ANDAs") for betamethasone dipropionate cream (augmented), 0.05% and betamethasone dipropionate gel (augmented), 0.05%.
The Taro products are bioequivalent to Schering-Plough's Diprolene AF cream and Diprolene gel. Augmented betamethasone dipropionate cream and gel are prescription topical corticosteroid products used primarily in managing inflammatory skin conditions. As with the bioequivalent Diprolene products, the vehicles of the Taro cream and gel products augment the penetration of the active ingredient into the skin.
According to industry sources, Diprolene AF cream and Diprolene gel had 12-month US sales of approximately $54 million and $6 million, respectively, through the third quarter of 2003. "These products offer physicians and patients high quality generic alternatives when augmented formulations of betamethasone dipropionate are indicated," said Taro chairman Barrie Levitt, MD.
Currently, Taro has 32 filings at the FDA: 31 ANDAs, which include two tentative approvals and two unique supplemental ANDAs, plus a New Drug Application related to the company's NonSpil liquid drug delivery system. In addition, the company has multiple regulatory filings in Canada, Israel and other countries around the world.
Published by Globes [online] - www.globes.co.il - on 10 December 2003