What is Granules Pharmaceuticals' new ADHD drug?

Granules Pharmaceuticals received tentative FDA approval for Amphetamine Extended-Release Tablets, a generic version of Dyanavel XR, for treating ADHD.

How will the FDA approval affect ADHD treatment costs in the US?

The approval of Granules' generic ADHD medication is expected to significantly improve affordability and access to treatment for many patients in the US.

What is ADHD and how is it treated?

ADHD is a neurodevelopmental condition characterized by inattention and hyperactivity. Treatment typically involves behavioral therapy, medication, or a combination of both.

Home / Business and Economy / Generic ADHD Drug Boosts US Access

Generic ADHD Drug Boosts US Access

8 Jan

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Summary

Granules Pharmaceuticals received tentative FDA approval for generic ADHD medication.
The approval targets an estimated US market of USD 41 million.
Generic version expected to improve ADHD treatment affordability and access.

Granules Pharmaceuticals, based in Hyderabad, has achieved a significant milestone with tentative approval from the US Food and Drug Administration (FDA) for its generic Attention Deficit Hyperactivity Disorder (ADHD) medication. This approval pertains to Amphetamine Extended-Release Tablets, a generic alternative to Dyanavel XR, in strengths of 5 mg, 10 mg, 15 mg, and 20 mg.

The US drug regulators have also granted the company an Abbreviated New Drug Application (ANDA) that qualifies for a 180-day exclusivity period. This provision allows Granules a limited window of market exclusivity during the initial phase of commercialization, aiming to facilitate a smoother market entry. The approval addresses an estimated US market valued at approximately USD 41 million.