Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

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Intellipharmaceutics files generic 30 mg Focalin XR ANDA with FDA

Intellipharmaceutics International Inc., today announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for approval to market a generic of the 30 mg strength of Focalin XR® (dexmethylphenidate hydrochloride). The application for the 30 mg strength is filed as an amendment to the ANDA that Intellipharmaceutics had previously filed for the 5, 10, 15 and 20 mg strengths of the drug.

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Tags: Allergy and Immunology, ADHD Medication, Drug, Phase 1 Clinical Trial, Biotech, FDA, Focalin