Indoco Remedies Canagliflozin Tablets for type 2 diabetes adults get USFDA tentative okay

Mumbai: Indoco Remedies Ltd. has announced the receipt of tentative approval from the United States Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets 100 mg and 300 mg.

The product is a generic equivalent of the Reference Listed Drug, Invokana Tablets 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc.

This product will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at Goa (Plant -I) in India.

Canagliflozin improves glycemic control in adults with type 2 diabetes mellitus.

Commenting on the achievement, Ms. Aditi Panandikar, Managing Director said, “Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.”