Tag: United States Food and Drug Administration

U.S. FDA issues warning letter to Natco over facility near Hyderabad

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U.S. FDA issues warning letter to Natco over facility near Hyderabad

Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest. | Photo Credit: Reuters The United States Food and Drug Administration (U.S. FDA) has issued a warning letter to Natco Pharma over quality…

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Glenmark Pharma’s generic drug to treat psoriatic arthritis gets U.S. FDA approval 

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Glenmark Pharma’s generic drug to treat psoriatic arthritis gets U.S. FDA approval 

Drug-maker Glenmark Pharmaceuticals’ Apremilast Tablets, 10 mg, 20 mg and 30 mg, a generic version of Amgen’s Otezla Tablets, 10 mg, 20 mg and 30 mg, has received final approval from the United States Food and Drug Administration (U.S. FDA). Otezla Tablets brand and therapeutic equivalents achieved annual sales of around $3.7 billion, Glenmark said…

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