Mumbai, Feb. 27 -- Glenmark's Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial is both bioequivalent and therapeutically equivalent to the reference listed drug, Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL), from BPI Labs, LLC, NDA 205029. The launch of this product is eligible for 180 days of CGT exclusivity under Section 505(j)(5)(B)(v) of the Federal Food, Drug, and Cosmetic (FD&C) Act, it added.
Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.
According to IQVIATM sales data for the 12-month period e...