Elite Pharmaceuticals Receives FDA Approval for Generic Vyvanse
Key Insights
Elite Pharmaceuticals (search) has received FDA approval for its Abbreviated New Drug Application (ANDA) for a generic version of Vyvanse (Lisdexamfetamine Dimesylate).
The generic Vyvanse will be available in strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules, indicated for ADHD (search) treatment.
According to IQVIA, the annual sales for the brand and generic market of Vyvanse reached $4.3 billion for the twelve months ending September 2024.
Elite Pharmaceuticals (search), Inc. (OTCQB: ELTP) has secured FDA approval for its generic version of Vyvanse (Lisdexamfetamine Dimesylate), offering a new treatment option for Attention Deficit Hyperactivity Disorder (search) (ADHD (search)). The approval covers strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules.
The FDA's decision marks a significant milestone for Elite Pharmaceuticals (search), a company specializing in niche generic products. This approval allows them to enter a substantial market, with IQVIA reporting annual sales of $4.3 billion for Vyvanse and its generics for the year ending September 2024.
About Elite Pharmaceuticals
Elite Pharmaceuticals (search) focuses on developing, manufacturing, and distributing immediate-release and controlled-release solid oral dose products. These products are marketed under the Elite Laboratories label and through licenses with third-party organizations. The company operates a cGMP and DEA registered facility in Northvale, NJ, for research, development, and manufacturing.