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FDA Accepts sNDA for the De Novo Indication for ENVARSUS XR
April 23, 2018Veloxis Announces US Food and Drug Administration (FDA) Accepts Standard Review Company's Supplemental New Drug Application (sNDA) -
Allergan receives FDA’s RTF letter for Vraylar sNDA to treat schizophrenia
September 27, 2017Schizophrenia is a chronic and disabling disorder that leads to positive symptoms, including hallucinations, delusions and thought disorders, and negative symptoms, such as loss of motivation and social withdrawal. -
FDA accepts sNDA for Xeljanz for the treatment of adult patients with active ulcerative colitis
July 17, 2017Anticipated Prescription Drug User Fee Act (PDUFA) action date for the sNDA is March 2018 . -
FDA accepts sNDA for Vraylar
March 10, 2017Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia. -
U.S. FDA approves supplemental New Drug Applications to include landmark data in product labels for
January 06, 2017The U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications for three type 2 diabetes medicines within the empagliflozin family to include data from the landmark EMPA-REG OUTCOME® trial. -
FDA accepts for filing sNDA for Liletta 52 mg
January 06, 2017Application seeks to extend duration of use up to 4 years for Liletta.
Pharma Sources Insight January 2025
