FDA Approves DEXMETHYLPHENIDATE HYDROCHLORIDE — Granules Pharmaceuticals Inc.
Granules Pharmaceuticals Inc. received approval for its ANDA 213813 to manufacture and market Dexmethylphenidate Hydrochloride, the active ingredient in the ADHD drug Focalin, on September 9, 2020. This launch intensifies generic competition for the branded Focalin XR product, likely pressuring market share and driving price erosion in the stimulating medication space.
AI-generated summary for informational purposes only. Always verify against the original filing. Not investment advice. BriefTape is not a registered investment adviser.
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