New Delhi, Indoco Remedies on Thursday said it has received approval from the US health regulator to market its generic diabetes drug.
Indoco Remedies said in a regulatory filing that the company has received provisional approval from the US Food and Drug Administration (USFDA) for an abbreviated new drug application (ANDA) for canagliflozin and metformin hydrochloride tablets in various strengths.
The company's product is the generic equivalent of Invocamet tablets.
Indoco said it plans to produce the drug at its manufacturing facility in Goa.
Canagliflozin and metformin hydrochloride tablets are used to treat type 2 diabetes mellitus.
Aditi Panandikar, MD, Indoco Remedies, said, “This milestone underlines our commitment to bring affordable and effective treatment options to patients with type 2 diabetes.”
Indoco Remedies said in a regulatory filing that the company has received provisional approval from the US Food and Drug Administration (USFDA) for an abbreviated new drug application (ANDA) for canagliflozin and metformin hydrochloride tablets in various strengths.
The company's product is the generic equivalent of Invocamet tablets.
Indoco said it plans to produce the drug at its manufacturing facility in Goa.
Canagliflozin and metformin hydrochloride tablets are used to treat type 2 diabetes mellitus.
Aditi Panandikar, MD, Indoco Remedies, said, “This milestone underlines our commitment to bring affordable and effective treatment options to patients with type 2 diabetes.”
