Drug Approval | September 01, 2024
Biocon Pharma receives USFDA approval for daptomycin
The approval further adds to Biocon’s portfolio of complex drug products
The approval further adds to Biocon’s portfolio of complex drug products
Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
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
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation
Sevelamer Carbonate Tablets approval consolidates the company's position in the Sevelamer segment
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