Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study
Elite Pharmaceuticals reported positive results from pivotal bioequivalence studies for a generic extended-release drug in the dopamine agonist class. The studies confirmed that the generic product is bioequivalent to its branded counterpart. IQVIA reported an annual market revenue of $12 million for this product as of August 2022. Elite will file an Abbreviated New Drug Application with the FDA, supporting future growth potential. The company specializes in niche generic products and operates a cGMP and DEA registered facility in Northvale, NJ.
- Confirmation of bioequivalence for the new generic drug product.
- Potential market revenue of $12 million for the generic product.
- Intent to file an Abbreviated New Drug Application with the FDA.
- None.
Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study
NORTHVALE, NJ / ACCESSWIRE / November 2, 2022 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today reported positive results from pivotal fed and fasted bioequivalence studies for an undisclosed extended-release generic drug product in a class of medications called dopamine agonists. IQVIA reported annual revenue for the twelve months ending August 2022 of
The studies were single-dose crossover comparative bioavailability studies in healthy male and female volunteers in both the fed and fasting states. The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration.
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.
View source version on accesswire.com:
https://www.accesswire.com/723236/Elite-Pharmaceuticals-Reports-Positive-Results-from-a-Pivotal-Bioequivalence-Study
FAQ
What are the results reported by Elite Pharmaceuticals regarding their new drug?
What kind of drug is Elite Pharmaceuticals developing?
What is the market revenue for the drug Elite Pharmaceuticals is working on?
What is the next step for Elite Pharmaceuticals following their study results?
What is the location of Elite Pharmaceuticals' manufacturing facility?
