Dr. Reddy’s Labs, Slayback sign licensing deal for Brimonidine Tartrate
Dr. Reddy’s Laboratories said that it has signed a licensing deal with New Jersey-based Slayback Pharma for acquiring rights in the latter’s Brimonidine Tartrate Ophthalmic Solution 0.025%.
Brimonidine Tartrate Ophthalmic Solution 0.025% is the private label equivalent of Lumify in the US.
Lumify, which is an over-the-counter (OTC) eyedrop, can be used for easing the redness of the eye caused by minor eye irritations. The deal also gives exclusive rights to Dr. Reddy’s Laboratories to Brimonidine Tartrate Ophthalmic Solution 0.025% outside the US.
Marc Kikuchi — Dr. Reddy’s Laboratories North America Generics CEO said: “We are pleased to license this important OTC ophthalmic product for the U.S. market.
“This product complements Dr. Reddy’s growing OTC product portfolio in the eyecare category that includes the private label versions of Pataday Once Daily Relief and Pataday Twice Daily Relief.”
Slayback Pharma is said to be the first firm to submit an abbreviated new drug application (ANDA) for the private label equivalent for Lumify with the US Food and Drug Administration (FDA) under Paragraph IV certification.
Presently, the ANDA is under the review of the FDA and covers Brimonidine Tartrate Ophthalmic Solution 0.025% in the fill volumes of 2.5 ml and 7.5 ml.
Ajay Singh — Slayback Pharma CEO and Founder said: “Slayback is proud to develop this first-to-file ANDA for Lumify, a significant OTC product in the eye redness reliever category, that continues to highlight the R&D capability of the company.”