FDA grants final approval for Hi-Tech Pharmacal's Bromfenac Ophthalmic Solution ANDA

Jan 23 2014

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.