Trade Resources Policy & Opinion US FDA Granted Final Approval for The Company's Abbreviated New Drug Application

US FDA Granted Final Approval for The Company's Abbreviated New Drug Application

Tags: Health, Medicine

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.

Source: http://www.news-medical.net/news/20140123/FDA-grants-final-approval-for-Hi-Tech-Pharmacals-Bromfenac-Ophthalmic-Solution-ANDA.aspx
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FDA Grants Final Approval for Hi-Tech Pharmacal's Bromfenac Ophthalmic Solution Anda