Hi-Tech Pharmacal Receives Final Approval for Bromfenac Ophthalmic Solution, 0.09% (Once-A-Day)
January 23 2014 - 6:00AM
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 Bromfenac Ophthalmic
Solution, 0.09% (Once-A-Day), the generic for ISTA Pharmaceuticals’
Bromday ® ophthalmic solution, 0.09%. The product is used to treat
postoperative inflammation and reduction of ocular pain in patients
who have undergone cataract surgery. Hi-Tech plans to launch the
product immediately.
On August 27, 2013, the Company entered into a definitive
agreement under which Akorn, Inc. (“Akorn”) will acquire the
Company for $640,000,000 or $43.50 per share in cash. The
acquisition will be subject to customary conditions, including
termination of the waiting period under the provisions of the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
Pending the satisfaction of such customary conditions, the Company
anticipates closing the transaction in the first quarter of
2014.
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.
Hi-Tech Pharmacal Co., Inc.Bill Peters, 631-789-8228
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