Elite Pharmaceuticals Files ANDA with US FDA to Market Dopamine Agonist
Elite Pharmaceuticals has filed an Abbreviated New Drug Application (ANDA) with the FDA for an undisclosed extended-release generic drug in the dopamine agonists class. This medication had US sales of about $12 million for the year ending August 31, 2022, according to IQVIA. The company develops niche generic products and operates a cGMP facility in Northvale, NJ. While the filing is a strategic move, it involves inherent risks and uncertainties that could impact future performance.
- Filed ANDA for a generic dopamine agonist with $12 million in US sales potential.
- Specializes in niche generic products, enhancing market focus.
- Forward-looking statements highlight risks and uncertainties regarding FDA approval.
- Approval timing and product success are uncertain.
NORTHVALE, NJ / ACCESSWIRE / December 22, 2022 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for an undisclosed extended-release generic drug product in a class of medications called dopamine agonists. For the twelve months ending August 31, 2022, the dopamine agonist had total US sales of approximately
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma. 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.
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