Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets
Drug Approval

Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus

  • By IPP Bureau | June 07, 2024

Indoco Remedies Ltd. announced the receipt of tentative approval from the USFDA for Abbreviated New Drug Application (ANDA) for Canagliflozin and Metformin Hydrochloride Tablets, 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg, a generic equivalent of Invokamet Tablets, 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg and 150 mg/1000 mg.

This product, Canagliflozin and Metformin Hydrochloride Tablets, will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at Verna Industrial Area, Verna, Goa in India. Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus.

Commenting on the achievement, Aditi Panandikar, Managing Director said, "We are excited to receive the tentative approval from the USFDA for our Canagliflozin and Metformin Hydrochloride Tablets. This milestone underscores our commitment to bringing affordable and effective treatment options to patients managing type 2 diabetes."

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