Hi-Tech Pharmacal Receives Approval For Hydrocodone Bitartrate And Homatropine Methylbromide Syrup

Main Category: Flu / Cold / SARS
Also Included In: Regulatory Affairs / Drug Approvals;  Respiratory / Asthma
Article Date: 13 Feb 2008 - 1:00 PDT

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Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the US Food and Drug Administration (FDA) has granted an approval to the Company's Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Homatropine Methylbromide Syrup, the generic equivalent of Endo Pharmaceuticals' Hycodan®. Hydrocodone Bitartrate and Homatropine Methylbromide Syrup is indicated for the symptomatic relief of cough and had sales of approximately $5 million for 2006 according to IMS. The Company expects to start marketing the product immediately.

About Hi-Tech Pharmacal

Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded products. 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 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 results of new information, future events or otherwise.

Hi-Tech Pharmacal