FDC Ltd. has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Timolol Maleate Ophthalmic Solution. Timolol Maleate Ophthalmic Solution is a nonselective beta-blocking drug, used as a primary line of treatment for glaucoma.

Akorn announced that it has received FDA approval for its Ofloxacin Ophthalmic Solution USP, 0.3%. Ofloxacin Ophthalmic Solution USP, 0.3%, is the generic version of Ophthalmic Solution to treat infections caused by bacteria in conjunctivitis and corneal ulcers. The branded drug had generated sales of approximately $7.5 million in 2007. Akorn plans to manufacture the generic drug in its Decatur, Illinois, facility, and expects to launch the drug in the third quarter of 2008.

Sirion Therapeutics Inc. has received FDA approval for its New Drug Application (NDA) for Durezol(TM). The FDA has granted the drug priority review, which means that the review would be completed in six months from the date of receipt of the NDA. The NDA is for Sirion Therapeutics’ investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a twice-daily steroid, as a treatment for postoperative ocular inflammation.