Granules India got approval for ADHD drug from USFDA

Drug firm Granules India said its subsidiary has received approval from the US health regulator for Methylphenidate Hydrochloride extended-release capsules, used for the treatment of attention deficit hyperactivity disorder (ADHD). The approved product is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis Pharmaceuticals Corporation.

The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India, for Methylphenidate Hydrochloride extended-release capsules in the strengths of 10 mg, 20 mg, 30 mg, 40 mg and 60 mg.

Till date Granules Pharmaceuticals, Inc. had submitted total 19 ANDAs and the current approval is the third ANDA approval for the entity. Approvals for the balance 16 ANDAs are awaited.

What is Attention Deficit Hyperactivity Disorder (ADHD)?

  • Attention-deficit/hyperactivity disorder (ADHD) is a brain disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.
  • Despite being the most commonly studied and diagnosed mental disorder in children and adolescents, the exact cause is unknown in the majority of cases.
  • ADHD management recommendations vary by country and usually involve some combination of counseling, lifestyle changes, and medications

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