Feb 162016
 

February 16, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Azelaic Acid azelaic acid Gel;Topical Glenmark Pharms Inc Tentative Approval
Breo Ellipta fluticasone furoate; vilanterol trifenatate Powder;Inhalation Glaxo Grp Ltd Labeling Revision
Desvenlafaxine Succinate desvenlafaxine succinate Tablet, Extended Release;Oral Roxane Approval
Desvenlafaxine Succinate desvenlafaxine succinate Tablet, Extended Release;Oral Roxane Approval
Klaron sulfacetamide sodium Lotion;Topical Valeant Pharms North Manufacturing Change or Addition
Nitrofurantoin nitrofurantoin, macrocrystalline Capsule;Oral Sun Pharm Inds Approval
Toujeo Solostar insulin glargine recombinant Solution;Subcutaneous Sanofi Us Services Manufacturing Change or Addition
Viread tenofovir disoproxil fumarate Tablet;Oral Gilead Sciences Inc Labeling Revision
Viread tenofovir disoproxil fumarate Powder;Oral Gilead Sciences Inc Labeling Revision