Lupin Receives Tentative FDA Approval for Generic Version of Lumify

India-based generic drug maker Lupin has received tentative approval from the FDA for its abbreviated new drug application (NDA) for brimonidine tartrate ophthalmic solution 0.025% to market a generic equivalent of Lumify ophthalmic solution 0.025% (Bausch + Lomb). This product will be manufactured at Lupin’s Pithampur facility in India.

Brimonidine tartrate ophthalmic solution 0.025% is an OTC product indicated to relieve redness of the eye due to minor eye irritations.

In December 2023, Lupin received FDA approval for a generic equivalent to Bausch + Lomb's Alrex for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. In August 2023, Lupin received FDA approval for the generic equivalent of B+L's Bromday for the treatment of postoperative inflammation and pain.