RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 LITESPARK-005 trial investigating WELIREG, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2?) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies. In the study, WELIREG demonstrated a statistically significant improvement in one of the trial’s dual primary endpoints of progression-free survival (PFS) and in a key secondary endpoint of objective response rate (ORR) compared to everolimus. These late-breaking data are being presented for the first time today during a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2023 (abstract #LBA88) and are also being discussed with regulatory authorities worldwide.
Par Pharm`s Generic Everolimus Receives Approval in US
Biocon expands its Generic Formulations portfolio with the launch of Everolimus tablets in the US
Natco Pharma Limited announced that its marketing partner Breckenridge Pharmaceutical, Inc., US has launched the 10mg strength of everolimus tablets (generic for Afinitor) in the US market.
BERLIN, Conn., March 8, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Everolimus Tablets (generic for Afinitor®). This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, Afinitor and its therapeutic equivalents generated annual sales of $712 million during the twelve months ending December 2020. Breckenridge plans to launch Everolimus Tablets in 2.5mg, 5mg and 7.5mg strengths during the second quarter of 2021 in a blister card packaging configuration. Breckenridge's launch of the product's 10mg strength is based on terms that are presently confidential and will be announced at a later date.
BERLIN, Conn., March 8, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Everolimus Tablets (generic for Afinitor®). This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, Afinitor and its therapeutic equivalents generated annual sales of $712 million during the twelve months ending December 2020. Breckenridge plans to launch Everolimus Tablets in 2.5mg, 5mg and 7.5mg strengths during the second quarter of 2021 in a blister card packaging configuration. Breckenridge's launch of the product's 10mg strength is based on terms that are presently confidential and will be announced at a later date.
Mylan`s Generic Everolimus Receives Approval In US
Hikma`s Generic Everolimus Receives Approval In US
Mylan Pharms's Generic Everolimus Receives Approval In Us
Teva Pharms Generic Everolimus Receives Approval in US