Elite Pharmaceuticals Receives FDA Approval for Generic Requip XL

Reuters

Nov 12

Elite Pharmaceuticals Receives FDA Approval for Generic Requip XL

Elite Pharmaceuticals Inc. announced that it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP) in 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg strengths. The product, intended for the treatment of Parkinson's disease symptoms, will be marketed under the Elite Laboratories, Inc. label. According to IQVIA, the branded product and its equivalents recorded US sales of $10 million for the twelve months ending September 2025. The approval is exclusive to Elite Pharmaceuticals Inc.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Elite Pharmaceuticals Inc. published the original content used to generate this news brief via Newsfile (Ref. ID: 273940) on November 12, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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ID: 273940) on November 12, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1791710582.SGD","symbol_name":"Fidelity Global Demographics A-ACC-SGD (SGD/USD hedged)","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251112:nNDLbjJWzB:1","article_id":"2582373018","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2582373018","pubTimestamp":1762948976,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Elite Pharmaceuticals Inc. announced that it has received approval from the US Food and Drug Administration  for its Abbreviated New Drug Application  for a generic version of Requip XL  in 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg strengths. 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