Zydus Lifesciences on Wednesday has received approval from the US health regulator to market a generic diabetes drug in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg, the drug firm said in a statement. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The company said the tablets will be manufactured at its formulation manufacturing facility at SEZ, Ahmedabad. As per the industry estimates, Dapagliflozin tablets had annual sales of USD 10,486.9 million in the US. Zydus shares on Wednesday ended 0.23 per cent up at Rs 905 apiece on BSE.
Move comes just months before nivolumab patent expiry in India on May 2, 2026
Systematix said the recent US FDA approval of Zycubo, a Menkes disease treatment marketed by Sentynl Therapeutics, significantly enhances the company's growth outlook
The Delhi High Court has allowed Zydus Lifesciences to sell its nivolumab biosimilar, citing public interest, while directing the firm to maintain audited sales accounts pending the patent case
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The drug, CUTX-101, is intended for the treatment of Menkes disease, a rare X-linked recessive genetic disorder affecting male children
Zydus Lifesciences on Wednesday said it has launched a biosimilar for the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. The company has launched Zyrifa, a Denosumab biosimilar. Denosumab is a monoclonal antibody with several indications related to bone health, primarily in the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. This will provide access and treat patients with bone metastases due to breast, prostate, lung, myeloma, kidney, thyroid, head & neck, and other solid tumours, the Ahmedabad-based drug firm said in a regulatory filing. Metastases, is when the cancer spreads to the bones and other organs in the body indicating an advanced stage of cancer. The company said it has priced 'Zyrifa' at MRP of Rs 12,495. Sharvil P Patel, Managing Director, Zydus Lifesciences Ltd said that with Denosumab 120 mg SC, the company aims to bring access, affordability of medication in cancer patients ...
Zydus Lifesciences shares rose 2 per cent on Wednesday after it announced two key developments aimed at expanding its biosimilar portfolio
Zydus will commercialise FYB206 in North America, while Formycon will lead development, regulatory filings and supply, with a US FDA filing expected soon