Elite Pharmaceuticals (OTCMKTS:ELTP) Receives FDA Approval for Generic Vyvanse®

On November 18, 2024, Elite Pharmaceuticals, Inc. (Elite) announced in a press release that it had secured approval from the US Food and Drug Administration (FDA) for a generic version of Vyvanse® (Lisdexamfetamine Dimesylate), featuring strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules. Vyvanse® is classified as a central nervous system (CNS) stimulant and is primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The product will be commercialized under the Elite Laboratories, Inc. label.

The press release stated that the approval for the generic version of Vyvanse® was received on November 15, 2024. This significant development positions Elite Pharmaceuticals in a favorable position within the generic pharmaceuticals market, offering a cost-effective alternative for patients in need of ADHD medication.

According to the IQVIA report, the brand and generic market for Vyvanse® recorded annual sales of $4.3 billion for the twelve months ending in September 2024, indicating a substantial market potential for Elite Pharmaceuticals’ newly approved product.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development, manufacturing, and distribution of niche generic products, particularly immediate-release and controlled-release solid oral dose medications. These products are marketed under the Elite Laboratories brand and through licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and production, located in Northvale, New Jersey.

The company’s press release also contained forward-looking statements regarding potential implications on future performance related to the FDA approval. It cautioned that actual results may vary due to risks, uncertainties, and external factors beyond Elite’s control. Elite Pharmaceuticals is committed to adhering to FDA guidelines and ensuring compliance with regulatory standards to maintain product quality and efficacy.

For more details about Elite Pharmaceuticals, Inc. and its product portfolio, interested parties can visit the company’s website at www.elitepharma.com.

Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
[email protected]

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Elite Pharmaceuticals’s 8K filing here.

About Elite Pharmaceuticals

Elite Pharmaceuticals, Inc, a specialty pharmaceutical company, engages in the development, manufacture, and sale of oral, controlled-release products, and generic pharmaceuticals. The company operates in two segments, Abbreviated New Drug Applications for Generic Pharmaceuticals and New Drug Applications for Branded Pharmaceuticals.