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Generic ADHD Drug Boosts US Access
8 Jan
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.
This development is poised to enhance treatment accessibility and affordability for individuals with ADHD, who often face high costs associated with branded medications. The availability of a generic version ensures that patients will have access to a lower-cost alternative that meets the same stringent safety, quality, and effectiveness standards as the original drug.
