US FDA approves Hi-Tech Pharmacal’s bromfenac ophthalmic solution, 0.09%

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Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, has received the the US Food and Drug Administration, (FDA) final approval for its Abbreviated New Drug Application, (ANDA) for bromfenac ophthalmic solution, 0.09 per cent (Once-A-Day), the generic for ISTA Pharmaceuticals’ Bromday ophthalmic solution, 0.09 per cent.

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. 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.

Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products.

Source: Pharmabiz


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