• COVID-19
  • Biosimilars
  • Cataract Therapeutics
  • DME
  • Gene Therapy
  • Workplace
  • Ptosis
  • Optic Relief
  • Imaging
  • Geographic Atrophy
  • AMD
  • Presbyopia
  • Ocular Surface Disease
  • Practice Management
  • Pediatrics
  • Surgery
  • Therapeutics
  • Optometry
  • Retina
  • Cataract
  • Pharmacy
  • IOL
  • Dry Eye
  • Understanding Antibiotic Resistance
  • Refractive
  • Cornea
  • Glaucoma
  • OCT
  • Ocular Allergy
  • Clinical Diagnosis
  • Technology

European panel OKs Yellox

Article

CROMA Pharma, GmbH, and Bausch + Lomb (B + L) have announced the approval 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).

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.

Related Videos
Video 2 - 1 KOL is featured in, "Advances in Technology for SMILE procedure"
Video 1 - 1 KOL is featured in, "Overview of Small Incision Lenticule Extraction (SMILE)"
Vicki Chan, MD, shares pearls for leveraging the power of social media in health care
EyeCon 2024: Peter J. McDonnell, MD, marvels on mentoring, modern technology, and ophthalmology’s future
Lorraine Provencher, MD, presenting slides
© 2024 MJH Life Sciences

All rights reserved.