Drug Approval | September 06, 2024
Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
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)
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
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