You are here

Ammonium Lactate Cream Approved To Treat Xerosis, Bioequivalent to Lac-Hydrin

HAWTHORNE, N.Y.--(BUSINESS WIRE)--April 10, 2003--Taro Pharmaceutical Industries Ltd. (Nasdaq/NMS: TARO - News) reported today that its U.S. affiliate has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for ammonium lactate cream, 12%.

Taro's ammonium lactate cream is bioequivalent to Bristol-Myers Squibb's Lac-Hydrin® cream. Ammonium lactate cream is a prescription product used for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris and for temporary relief of itching associated with these conditions. According to industry sources, 2002 U.S. sales of ammonium lactate cream products were approximately $34.5 million.

"Ammonium lactate cream gives physicians and patients an affordable option in treating skin disorders such as xerosis and ichthyosis vulgaris," said Barrie Levitt, M.D., Chairman of the Company. "This new product further enhances Taro's position as a leading supplier of topical dermatological products."

Currently, Taro has 23 filings at the FDA: 21 ANDAs, including one tentative approval, one unique supplemental ANDA, and a New Drug Application related to the Company's NonSpil(TM) liquid drug delivery system. In addition, the Company has multiple regulatory filings in Canada, Israel and other countries around the world.

Taro is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at www.taro.com.

Recent Headlines

Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs