Drug Approval | August 20, 2024
Granules India receives ANDA approval for Glycopyrrolate Oral Solution
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
Glycopyrrolate Oral Solution is an anticholinergic medication indicated for pediatric patients
Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC) is indicated to relieve redness of the eye due to minor eye irritations.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries
The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2
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