CDER New July 1, 2014

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 1, 2014


New and Generic Drug Approvals

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

 

June 30, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Argatroban argatroban Injectable;Injection Par Sterile Products Approval
Argatroban argatroban Injectable;Injection Mylan Institutional Approval
Butrans buprenorphine Film, Extended Release;Transdermal Purdue Pharma Lp Labeling Revision
Butrans buprenorphine Film, Extended Release;Transdermal Purdue Pharma Lp Manufacturing Change or Addition
Chloraprep One-Step chlorhexidine gluconate; isopropyl alcohol Sponge;Topical Carefusion Labeling Revision
Chloraprep One-Step Frepp chlorhexidine gluconate; isopropyl alcohol Sponge;Topical Carefusion Labeling Revision
Chloraprep One-Step Sepp chlorhexidine gluconate; isopropyl alcohol Swab;Topical Carefusion Labeling Revision
Chloraprep Single Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Carefusion Labeling Revision
Chloraprep Triple Swabstick chlorhexidine gluconate; isopropyl alcohol Swab;Topical Carefusion Labeling Revision
Chloraprep With Tint chlorhexidine gluconate; isopropyl alcohol Sponge;Topical Carefusion Labeling Revision
Faslodex fulvestrant Injectable;Intramuscular Astrazeneca Manufacturing Change or Addition
Herceptin trastuzumab Vial; Intravenous Genentech Labeling Revision
Hibiclens chlorhexidine gluconate Solution;Topical Molnlycke Hlth Labeling Revision
Myalept metreleptin Injectable;Injection Amylin Pharms Llc Labeling Revision

 


This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery