Taro Receives FDA Approval for Alclometasone Dipropionate Cream USP, 0.05% ANDA; Tentative ANDA Approval Received for Gabapentin Capsules in 3 Strengths.

HAWTHORNE, N.Y. -- Taro Pharmaceutical Industries Ltd. ("Taro," Nasdaq: TARO) reported today that Taro Pharmaceuticals U.S.A., Inc. ("Taro USA") has received approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Alclometasone Dipropionate Cream USP, 0.05% ("alclometasone cream").

Taro's alclometasone cream is bioequivalent to GlaxoSmithKline's Aclovate(R) Cream. Alclometasone cream is a topical corticosteroid prescription product used for the treatment of inflammatory skin conditions in adults and in pediatric patients one year of age or older. According to industry sources, Aclovate(R) Cream has annual U.S. sales of approximately $8.4 million. Taro USA also markets Alclometasone Dipropionate Ointment USP, 0.05%.

Gabapentin Capsules Tentative Approval

Taro also reported that it has received tentative approval from the FDA for its ANDA for Gabapentin Capsules 100 mg, 300 mg, and 400 mg ("gabapentin capsules"). Gabapentin capsules are used in treating epilepsy and postherpetic neuralgia.

The tentative approval for gabapentin capsules is an FDA determination that Taro's ANDA submission for these products 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's gabapentin capsules are intended to be marketed as generic equivalents to Pfizer's Neurontin(R) Capsules in the same strengths upon final approval of Taro's ANDA.

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, 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 alclometasone cream and ointment and gabapentin capsules. 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 alclometasone or gabapentin products and the Company's other products; 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.