First Generic Of B+L’s OTC Switch Lumify Approved For Dr. Reddy’s Amid Patent Infringement Battle

Canadian firm received approval from FDA for NDA submitted in May 2023 for Lumify Preservative Free. A month earlier, FDA approved Dr. Reddy's ANDA submitted in July 2021 for an equivalent of Lumify’s formulation, brimonidine tartrate 0.025% ophthalmic solution.

• Source: Shutterstock

Bausch + Lomb, Corporation received approval to extend its Lumify eye drop line with a preservative-free formulation a month after the first generic of the brimonidine tartrate OTC switch was approved as B+L litigates to protect its patents for the product.

The Canadian firm, which announces its latest results on 1 May, received approval from the Food and Drug Administration in a 19 April letter for its new drug application submitted in May 2023 for Lumify Preservative Free (brimonidine tartrate 0.025% ophthalmic solution). The agency’s Center for Drug Evaluation and Research notes in the

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Rx-to-OTC Switch

More from Health