Elite Pharmaceuticals Files ANDA with US FDA to Market Central Nervous System Stimulant

Rhea-AI Summary

Elite Pharmaceuticals, Inc. (ELTP) announced FDA acceptance for review of an Abbreviated New Drug Application (ANDA) for an undisclosed generic drug product in the central nervous stimulants class. IQVIA reported annual sales of $5.1 billion for the brand and generic market for this product.

NORTHVALE, NJ / ACCESSWIRE / December 26, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today announced the US Food and Drug Administration's (FDA) acceptance for review of an Abbreviated New Drug Application (ANDA) on December 21, 2023, for an undisclosed generic drug product in a class of medications known as central nervous stimulants. IQVIA reported annual sales for the twelve months ending June 2023 of $5.1 billion for the brand and generic market for this product.

About Elite Pharmaceuticals, Inc.

Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite's product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties, and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com

SOURCE: Elite Pharmaceuticals, Inc.

View the original press release on accesswire.com

What did Elite Pharmaceuticals, Inc. announce?

Elite Pharmaceuticals, Inc. announced FDA acceptance for review of an Abbreviated New Drug Application (ANDA) for an undisclosed generic drug product in the central nervous stimulants class.

When did the announcement take place?

The announcement took place on December 21, 2023.

What is the ticker symbol for Elite Pharmaceuticals, Inc.?

The ticker symbol for Elite Pharmaceuticals, Inc. is ELTP.

What were the annual sales reported by IQVIA for the product?

IQVIA reported annual sales of $5.1 billion for the brand and generic market for this product.