Elite Pharmaceuticals Receives FDA Approval for Generic Methotrexate
Elite Pharmaceuticals announced FDA approval for its generic Methotrexate Sodium 2.5 mg tablets. This approval relates to an Abbreviated New Drug Application (ANDA) and adds to Elite's portfolio of niche generic products. The generic Methotrexate, classified as an antimetabolite, will be marketed under Elite Laboratories. According to IQVIA, the generic market for Methotrexate had annual sales of $64.3 million for the twelve months ending March 2024. Elite Pharmaceuticals focuses on developing, manufacturing, and distributing immediate-release and controlled-release solid oral dose products, operating from a cGMP and DEA registered facility in Northvale, NJ.
- FDA approval for generic Methotrexate Sodium 2.5 mg tablets
- Addition to Elite's niche generic product portfolio
- Methotrexate is a widely used antimetabolite
- IQVIA reported $64.3 million annual sales for the generic Methotrexate market
- No financial impact or revenue projections provided
- Potential market competition in the generic Methotrexate segment
NORTHVALE, NJ / ACCESSWIRE / May 20, 2024 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for generic Methotrexate Sodium 2.5 mg tablets. Methotrexate belongs to a class of drugs known as antimetabolites and will be sold under the Elite Laboratories, Inc. label. IQVIA reported annual sales of
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
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