CROMA and B&L's eye drug Yellox approved by the European Commission

3 June 2011

Austria-based CROMA Pharma GmbH, a private global specialty pharmaceutical and surgical company, and eye health major Bausch & Lomb have announced the approval of their Yellox (bromfenac sodium sesquihydrate) by the European Commission. This news follows the positive opinion issued earlier in March by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA).

Yellox, a non-steroidal anti-inflammatory drug (NSAID), is now approved for the treatment of postoperative ocular inflammation following cataract extraction in adults. Cataract surgery is one of the most common surgeries worldwide.

CROMA, the holder of the Yellox Marketing Authorization, filed its application through the European Union-centralized approval procedure seeking simultaneous approval in all 27 member states. Yellox is the first ocular NSAID dosed twice a day to receive such an approval, the company said.

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