Elite Pharmaceuticals Receives FDA Approval for Generic Methotrexate
Elite Pharmaceuticals Receives FDA Approval for Generic Methotrexate
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 $64.3 million for the twelve months ending March 2024 for the generic market for this product.
新澤西州諾斯維爾/ACCESSWIRE/2024年5月20日/開發利基仿製藥的專業製藥公司Elite Pharmicals, Inc.（“Elite” 或 “公司”）（OTCQB: ELTP）今天宣佈，其仿製甲氨蝶呤鈉2.5毫克片劑的縮寫新藥申請（ANDA）已獲得美國食品藥品監督管理局（FDA）的批准。甲氨蝶呤屬於一類被稱爲抗代謝物的藥物，將以Elite Laboratories, Inc. 的標籤出售。IQVIA報告稱，在截至2024年3月的十二個月中，該產品的仿製藥市場的年銷售額爲6,430萬美元。
About Elite Pharmaceuticals, Inc.
關於精英制藥有限公司
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 .
Elite Pharmaceuticals, Inc. 是一家開發、製造和分銷利基仿製藥產品的專業製藥公司。Elite的產品線包括即釋和控釋固體口服劑量產品，這些產品以Elite Laboratories的標籤銷售，並根據授予第三方藥品營銷和分銷組織的許可進行銷售。Elite在新澤西州諾斯維爾運營着一家經過cGMP和美國藥物管理局註冊的研究、開發和製造設施。欲了解更多信息，請訪問。
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.
本新聞稿包含1995年《私人證券訴訟改革法》所指的 “前瞻性陳述”，包括但不限於與對未來業績、業績或其他預期的影響（如果有）相關的陳述，這些影響可能與本新聞稿的主題有一定關係。請讀者注意，此類前瞻性陳述涉及但不限於Elite無法控制的風險、不確定性和其他因素，這些因素可能導致Elite的實際業績、業績或成就與這些前瞻性陳述可能暗示的業績、業績或其他預期存在重大差異。這些前瞻性陳述可能包括有關FDA批准產品的預期時間（如果有的話）以及FDA爲獲得此類批准可能要求Elite採取的行動的陳述。這些前瞻性陳述並不能保證未來的行動或業績。Elite向美國證券交易委員會提交的文件中不受限制地討論了這些風險和其他因素，包括其10-K、10-Q和8-K表的報告。無論是由於新信息、未來事件還是其他原因，Elite沒有義務更新或修改其前瞻性陳述。
Contact:
聯繫人：
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
精英制藥有限公司
Dianne Will，投資者關係
518-398-6222
Dianne@elitepharma.com
SOURCE: Elite Pharmaceuticals, Inc.
來源：精英制藥公司
譯文內容由第三人軟體翻譯。