Feb 172016
 

February 17, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Afrezza insulin recombinant human Powder;Inhalation Sanofi Aventis Manufacturing Change or Addition
Efavirenz efavirenz Tablet; Oral Matrix Labs Ltd Approval
Harvoni ledipasvir; sofosbuvir Tablet;Oral Gilead Sciences Inc Labeling Revision
Kinevac sincalide Injectable;Injection Bracco Manufacturing Change or Addition
Methylprednisolone Sodium Succinate methylprednisolone sodium succinate Injectable;Injection Hikma Farmaceutica Approval
Opsumit macitentan Tablet;Oral Actelion Pharms Ltd Labeling Revision