Indoco Receives Tentative USFDA Nod for Generic Diabetes Medication

Indoco Remedies Ltd has secured a significant win, receiving tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA). This paves the way for the company to market a generic version of Invokamet® Tablets, a medication used to treat type 2 diabetes mellitus.

The approved generic comes in four dosages: 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg, and 150 mg/1000 mg of canagliflozin and metformin hydrochloride. Indoco will manufacture these tablets at their facility in Goa, India.

This tentative approval is a crucial first step for Indoco to launch its generic alternative in the US market. The company is expected to complete the remaining requirements for final approval in the coming months. If successful, this generic medication could provide patients with a more affordable treatment option for managing type 2 diabetes.

“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,” said Ms Aditi Panandikar, Managing Director.

The US FDA granted Indoco final approval in May 2024 for the Abbreviated New Drug Application (ANDA) for Pregabalin capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg. This is a generic version of Upjohn US 2 LLC’s Reference Listed Drug, Lyrica® Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.

Pregabalin capsules will be produced by Indoco Remedies Limited at its plant at L-14, Verna Industrial Area, Verna, Goa—403722 in India. Pregabalin is used to treat fibromyalgia, postherpetic neuralgia, and neuropathic pain related to diabetic peripheral neuropathy and spinal cord injury.

About Indoco Remedies Limited

Indoco Remedies (Indoco) is a Mumbai-based pharmaceutical company that focuses on formulations and is present in contract manufacturing and research. On June 07, 2024, Indoco Remedies shares opened at ₹324.60 and touched the day high of ₹324.60 at 12:10 PM.

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