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Hi-Tech Pharmacal Receives Final Approval for Levofloxacin Oral Solution

^{Published on 2011-06-21 04:10:44 - Market Wire}
 

AMITYVILLE, N.Y.--([ BUSINESS WIRE ])--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for levofloxacin oral solution 25mg/mL, the generic for McNeil Pharmaceutical's Levaquin® oral solution which had sales of $6 million for the 12 months ended December 2010 according to IMS sales data. The product is indicated for the treatment of adults with mild, moderate and severe infections. Hi-Tech plans to launch the product immediately. The Company filed the ANDA pursuant to 505(j)(2)(A)(vii)(IV) of the Food Drug and Cosmetic Act and the FDA confirmed that Hi-tech will have 180 day exclusivity related to its Paragraph IV patent challenge.

Hi-Tech currently has 13 products awaiting approval at the FDA, targeting brand and generic sales of over $1 billion. In addition, Hi-Tech has 20 products in active development targeting brand sales of over $4 billion, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays.

About Hi-Tech Pharmacal

Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC 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. Hi-Tech's ECR Pharmaceuticals subsidiary markets branded prescription products.

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.