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Tentative Approval Granted for Generic Version of Elocon
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(r) ointment and cream. According to industry sources, in 2003, U.S. sales of mometasone ointment products were approximately $16 million and U.S. sales of Elocon(r) cream were approximately $54 million.
Mometasone Cream Tentative Approval
Taro USA submitted its ANDA for mometasone cream to the FDA with a certification stating the Company's belief that the product does not infringe Schering's listed patents on Elocon(r) cream, commonly known as a Paragraph IV certification. 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.
The tentative approval for mometasone cream is an FDA determination that Taro USA's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities, restrictions and any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Source: Taro Pharmaceutical Industries Ltd.