Aurobindo Pharma Secures USFDA Approval for New Diabetes Medication
Aurobindo Pharma receives USFDA approval for Dapagliflozin and Metformin Hydrochloride XR Tablets
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Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. The products are bioequivalent to AstraZeneca's Xigduo XR Tablets and will be produced at APL Healthcare's facility.
- 01Aurobindo Pharma received USFDA approval for Dapagliflozin and Metformin Hydrochloride XR Tablets.
- 02The tablets are available in multiple dosages: 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg.
- 03The product is bioequivalent and therapeutically equivalent to AstraZeneca's Xigduo XR Tablets.
- 04Manufacturing will take place at APL Healthcare, a subsidiary of Aurobindo Pharma.
- 05The new medication will be launched immediately.
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Aurobindo Pharma has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. These tablets, available in dosages of 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, are bioequivalent and therapeutically equivalent to AstraZeneca's Xigduo XR Tablets. The approval allows Aurobindo to manufacture and market these products, which will be produced at Unit-IV of APL Healthcare, a wholly owned subsidiary of the company. The launch of the medication is set to occur immediately, expanding Aurobindo Pharma's portfolio in the diabetes treatment market.
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The approval and subsequent launch of these tablets may provide more affordable diabetes treatment options for patients in the US, potentially impacting their medication costs.
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