PharmaSages_April FDA ApprovalsNOVARTIS: ZYKADIA (ceritinib) is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. GLAXOSMITHKLINE: TANZEUM ((albiglutide) is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ELI LILLY: CYRAMZATM (RAMUCIRUMAB) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for the treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine- or platinum-containing chemotherapy.JANSSEN BIOTECH: SYLVANT (SILTUXIMAB) is an interleukin-6 (IL-6) antagonist indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.MERCK: Asmanex HFA* (MOMETASONE FUROATE) for maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

*A drug that appears to have therapeutic qualities similar to those of an already marketed drug.

New dosage form of EVZIO from KALEO, was approved. New formulation or new manufacturer for OMTRYG from TRYGG PHARMA, and PURIXAN from NOVA LABORATORIES were approved.

In addition, Vasostrict (vasopressin injection, USP) from PAR STERILE PRODUCTS was approved to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Vasostrict was already marketed without an approved NDA

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