Vienna, Austria and Berlin, Germany-CROMA Pharma, GmbH, and Bausch + Lomb (B + L) have announced the approval of bromfenac sodium sesquihydrate (Yellox) by the European commission. This news follows the positive opinion issued in March by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA).
A non-steroidal, anti-inflammatory drug (NSAID), bromfenac is now approved for the treatment of postoperative ocular inflammation following cataract extraction in adults.
CROMA, holder of the product’s marketing authorization, filed its application through the EU-centralized approval procedure, seeking simultaneous approval in all 27 member states. Bromfenac is the first ocular NSAID dosed twice a day to receive such an approval.
CROMA and B + L will co-promote bromfenac in Austria, France, Spain, Poland, and Romania; B + L will promote it in the remaining EU member states.
