Taro Receives Tentative Approval for Augmented Betamethasone Dipropionate Lotion ANDA
Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) reported today that Taro Pharmaceuticals U.S.A., Inc., its U.S. affiliate, has received tentative approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application for Betamethasone Dipropionate Lotion (Augmented) USP, 0.05% (“augmented betamethasone dipropionate lotion”).
The FDA has determined that Taro’s augmented betamethasone dipropionate lotion is safe and effective for use when compared with the reference listed drug product, Schering Corporation’s Diprolene(R) Lotion, 0.05% (Augmented).
Augmented betamethasone dipropionate lotion is a prescription product used in managing inflammatory skin conditions. According to industry sources, Diprolene(R) lotion has annual U.S. sales of approximately $12 million. Taro U.S.A. also markets betamethasone dipropionate augmented cream, augmented ointment, and augmented gel, as well as betamethasone dipropionate cream, ointment, and lotion.
The tentative approval for augmented betamethasone dipropionate lotion is an FDA determination that Taro’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.
Taro Pharmaceutical Industries Ltd. 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, please visit www.taro.com.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Taro’s new augmented betamethasone dipropionate lotion product. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated penetration of new markets; physician, pharmacist or patient acceptance of Taro’s augmented betamethasone dipropionate lotion; changes in the Company’s financial position; regulatory actions; and, other risks detailed from time to time in the Company’s SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.