Drug Approval | August 13, 2025
Indoco Remedies receives final USFDA approval for rivaroxaban tablets
Rivaroxaban is used to treat venous thromboembolism
Rivaroxaban is used to treat venous thromboembolism
The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA
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Marksans Pharma gets USFDA nod for acid reflux drug
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
The submission is supported by positive results from the Phase 3 AMPLIFY trial
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
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