USFDA6 Jun 2024, 07:57 pm
Indoco Remedies Receives Tentative ANDA Approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
AI Summary
Indoco Remedies Ltd. has 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. This product will be manufactured at their facility in Goa, India. The tablets are used to treat type 2 diabetes mellitus. The achievement underscores Indoco's commitment to bringing affordable and effective treatment options to patients managing type 2 diabetes.
Key Highlights
- Indoco Remedies receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
- Product is a generic equivalent of Invokamet® Tablets
- To be manufactured at Indoco's manufacturing facility in Goa, India
- Used to treat type 2 diabetes mellitus
- Highlights Indoco's commitment to affordable and effective treatment options