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New Delhi, Apr 7 (PTI) Aurobindo Pharma on Tuesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets used to control blood sugar levels in people with type 2 diabetes. The final approval granted by the US Food & Drug Administration (USFDA) to manufacture and market dapagliflozin tablets is for strengths 5 mg and 10 mg, Aurobindo Pharma said in a regulatory filing. These are bioequivalent and therapeutically equivalent to the refer ...Read More >
Mumbai/Naples: Lupin has taken a step forward in expanding its U.S. generics portfolio, securing regulatory progress for a key injectable product used in surgical care. Lupin has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Sugammadex Injection. The approval covers two dosage strengths -- 200 mg/2 mL and 500 mg/5 mL -- both in single-dose vial formats. The company's product has been deemed bioequivalent to Merck's Bridion i ...Read More >
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