Taro Pharmaceutical Industries (Nasdaq:TARO) reported at the end of last week that its US affiliate Taro Pharmaceuticals USA, has received approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for mometasone furoate ointment, USP 0.1%. In addition, Taro USA received tentative approval for its ANDA for mometasone furoate cream, USP 0.1%.
Taro's mometasone ointment and mometasone cream are prescription topical corticosteroid products used primarily for the relief of inflammatory skin conditions. The Taro products are generic versions of Schering-Plough's Elocon ointment and cream.
Taro stated that according to industry sources, in 2003, US sales of mometasone ointment products were approximately $16 million and US sales of Elocon cream were approximately $54 million.
Taro USA submitted its ANDA for mometasone cream to the FDA with a certification (commonly known as a Paragraph IV certification) stating the company's belief that the product does not infringe Schering's listed patents on Elocon cream. The FDA has informed Taro USA that another company has the right to an exclusive marketing period for the product, after which Taro USA expects to receive final approval from the FDA to market mometasone cream.
Taro noted that tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Published by Globes [online] - www.globes.co.il - on Sunday, December 05, 2004