Healthcare Industry News:  Dermik Laboratories 

Biopharmaceuticals Generics FDA

 News Release - April 17, 2007

Hi-Tech Pharmacal Receives Tentative Approval for Ciclopirox Topical Solution

AMITYVILLE, N.Y.--(HSMN NewsFeed)--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK ) announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for Ciclopirox topical solution, 8%. Hi-Tech's Ciclopirox topical solution is the generic equivalent of Dermik Laboratories' nail fungus treatment PenlacĀ® topical solution, 8%, which had sales of $87 million in 2006 based on IMS sales data. Final approval is expected upon expiration of the brand's patent on September 18, 2007.

Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing branded and generic prescription and OTC products for the general healthcare industry. The Company specializes in difficult to manufacture liquid and semi-solid dosage forms and produces a range of sterile ophthalmic, otic and inhalation products. The Company's Health Care Products Division is a leading developer and marketer of branded prescription and OTC products for the diabetes marketplace.

Forward-looking statements (statements which are not historical facts) in this press release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not promises or guarantees and investors are cautioned that all forward-looking statements involve risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, the regulatory environment, including without limitation, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results and other results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. These statements are based on management's current expectations and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward looking statements which speak only as of the date made. Hi-Tech is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.


Source: Hi-Tech Pharmacal

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