FDA accepts Teva & Medincell’s UZEDY sNDA for extended-release to treat BP-I
Teva Pharmaceuticals (TEVA) and Medincell (MEDCL) announced that the supplemental New Drug Application sNDA for UZEDY extended-release ...
Teva, Medincell announce FDA acceptance of sNDA for Uzedy
Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell announced that the supplemental New Drug ...
Pharm Exec5d
FDA Accepts Supplemental New Drug Application for Teva, Medincell’s Uzedy for Bipolar I Disorder
The application leverages existing clinical data for Uzedy along with prior FDA findings on the safety of Udezy in patients ...
The Pharma Letter6d
FDA accepts Teva and Medincell’s Uzedy sNDA
Israel-headquartered Teva Pharmaceutical Industries’ US subsidiary and France’s and Medincell announced that the supplemental ...
Investing6d
FDA accepts Teva, Medincell's supplemental application for UZEDY as bipolar I disorder treatment
UZEDY is currently approved for use every one or two months as a subcutaneous long-acting injectable (LAI) for the treatment ...
Teva targets schizophrenia to build on innovative medicines growth
The company is leaning on its subcutaneous technology to deliver long-acting options that could prevent patients from cycling through drugs.
FDA accepts Teva's application for Uzedy for bipolar I disorder
The FDA has accepted a supplemental New Drug Application submitted by Teva (NYSE:TEVA) and Medincell (OTC:MDCLF) for Uzedy ...
Investing6d
FDA accepts Teva, Medincell’s supplemental application for UZEDY as bipolar I disorder treatment
Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical (TASE:BLWV) Officer at Teva, said, "Since the FDA approval of UZEDY almost two years ago, it has proven to be an ...
Pharmabiz5d
Teva Pharma, Medincell announce US FDA acceptance of sNDA for Uzedy to treat people living with schizophrenia
Parsippany, New Jersey Thursday, February 27, 2025, 13:00 Hrs [IST] ...