Lupin receives USFDA’s tentative approval for Brimonidine Tartrate Ophthalmic Solution
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
The facility is a part of Lupin Manufacturing Solutions
This product will be manufactured at Lupin’s Pithampur facility in India
Subscribe To Our Newsletter & Stay Updated