Drug Approval | April 14, 2025
Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
The product will be launched in Q1FY26
The product will be launched in Q1FY26
The company expects to launch this product through its marketing partner in the near future
Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA
According to IQVIA sales data for the 12-month period ending January 2025, the Vancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial) market achieved annual sales of approximately $39.3 mn
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure
This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
Glenmark’s Clindamycin Phosphate Foam, 1% is bioequivalent and therapeutically equivalent to Evoclin Foam, 1%, of Mylan Pharmaceuticals.
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
According to IQVIATM sales data for the 12-month period ending November 2024, the Vitamin K1 Injectable Emulsion USP, 10 mg/mL market achieved annual sales of approximately $19.7 million
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