CDER New July 2, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 2, 2014


New and Generic Drug Approvals

July 2, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Azor amlodipine besylate; olmesartan medoxomil Tablet;Oral Daiichi Sankyo Labeling Revision
Bendamustine Hydrochloride Injection bendamustine hydrochloride Injectable; Injection Eagle Pharms Tentative Approval
Letairis ambrisentan Tablet;Oral Gilead Manufacturing Change or Addition
Norpramin desipramine hydrochloride Tablet;Oral Sanofi Aventis Us Labeling Revision
Qualaquin quinine sulfate Capsule;Oral Mutual Pharm Co Inc Labeling Revision

 

July 1, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Afinitor everolimus Tablet;Oral Novartis Labeling Revision
Afinitor Disperz everolimus Tablet, For Suspension;Oral Novartis Pharm Labeling Revision
Epiduo adapalene; benzoyl peroxide Gel;Topical Galderma Labs Lp Manufacturing Change or Addition
Iprivask desirudin recombinant Injectable;Subcutaneous Marathon Pharms Llc Manufacturing Change or Addition
Linzess linaclotide Capsule;Oral Forest Labs Inc Manufacturing Change or Addition
Lithium Citrate lithium citrate Syrup;Oral Roxane Manufacturing Change or Addition
M.V.I. Adult ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e; vitamin k Injectable;Iv (Infusion) Hospira Manufacturing Change or Addition
Premphase 14/14 estrogens, conjugated; medroxyprogesterone acetate Tablet;Oral-28 Wyeth Pharms Inc Manufacturing Change or Addition
Prempro estrogens, conjugated; medroxyprogesterone acetate Tablet;Oral-28 Wyeth Pharms Inc Manufacturing Change or Addition

 


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