Glenmark’s Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC), will be distributed in the U.S. by Glenmark Therapeutics, USA
The company will closely work with the USFDA to address and respond to the observations in an expeditious manner
Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients
Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of US$ 1,019 million in the US
Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market
Around 7% of the Indian population suffers from IBS
The observations are procedural in nature and will be responded to within the stipulated time
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
Combination shows consistent benefit across prespecified post-progression outcomes
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