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Ahmedabad: Zydus Lifesciences has expanded its presence in the U.S. generics market with a key regulatory approval for a widely used diabetes treatment. Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Dapagliflozin Tablets in 5 mg and 10 mg strengths. This approval enables the company to enter the U.S. market with a generic version of the drug, broadening its portfolio in a high-demand therapeutic category. With the approval, Zydus ...Read More >
Bengaluru: Biocon Limited has achieved a regulatory milestone in the United States, reinforcing its presence in the global diabetes treatment market. Biocon Pharma Limited, a subsidiary of Biocon Limited, has received approval from the U.S. Food and Drug Administration for Dapagliflozin Tablets in 5 mg and 10 mg strengths. The approval enables the company to market the drug for adults with type 2 diabetes mellitus, expanding its footprint in one of the world's largest pharmaceutical markets. T ...Read More >
New Delhi, Apr 8 (PTI) Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets indicated to control blood sugar in adults with type 2 diabetes mellitus. The approval by the US Food and Drug Administration (USFDA) is for dapagliflozin tablets of strengths 5 mg and 10 mg, Zydus Lifesciences said in a regulatory filing. Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycaemic co ...Read More >
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 >
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