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Hikma acquires Novugen's FDA-approved ANDA for trametinib
Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma.
About this update from Hikma Pharmaceuticals Plc
[{"type":"text","content":"LONDON, April 17, 2025 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma.","length":455,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Hikma Pharmaceuticals USA Inc.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Hikma Pharmaceuticals USA Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":108,"url":"https://media.zenfs.com/en/prnewswire.com/fcdee251665d184651b9926f5e9abe51"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/brP0E8SqJTDAbtPocMJv2A--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5MDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/fcdee251665d184651b9926f5e9abe51","width":400,"height":108}},"href":"https://mma.prnewswire.com/media/1165956/Hikma_Primary_Coral_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product.","length":192,"tagName":"p"},{"type":"text","content":""Hikma's Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers," said Dr. Hafrun Fridriksdottir, president of Hikma Generics. "Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans."","length":493,"tagName":"p"},{"type":"text","content":""As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US," said Rahil Mahmood, Chief Executive Officer of Novugen. "This exclusive first-to-file molecule is a testament to Novugen's innovation, regula...