CDER New June 30

FDA (U.S. Food and Drug Administration)

What's New on the FDA Drugs Site

July 30


New and Generic Drug Approvals

June 28, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ozurdex dexamethasone Implant;Intravitreal Allergan New or Modified Indication
Symbicort budesonide; formoterol fumarate dihydrate Aerosol, Metered;Inhalation Astrazeneca Manufacturing Change or Addition

 

June 27, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Afrezza insulin human Powder;Inhalation Mannkind Corp Approval
Ammonia N-13 ammonia n-13 Injectable;Intravenous Univ Tx Md Anderson Approval
Benicar olmesartan medoxomil Tablet;Oral Daiichi Sankyo Labeling Revision
Benicar Hct hydrochlorothiazide; olmesartan medoxomil Tablet;Oral Daiichi Sankyo Labeling Revision
Buprenorphine Hydrochloride and Naloxone Hydrochloride buprenorphine hydrochloride; naloxone hydrochloride Tablet;Sublingual Roxane Approval
Buprenorphine Hydrochloride and Naloxone Hydrodhcloride buprenorphine hydrochloride; naloxone hydrochloride Tablet;Sublingual Roxane Approval
Ceretec technetium tc-99m exametazime kit Injectable;Injection Ge Healthcare Manufacturing Change or Addition
Desmopressin Acetate desmopressin acetate Tablet;Oral Mylan Pharms Inc Approval
Doxorubicin Hydrochloride doxorubicin hydrochloride Injectable;Injection Actavis Inc Approval
Eletriptan Hydrobromide eletriptan hydrobromide Tablet; Oral Teva Pharms Usa Tentative Approval
Ella ulipristal acetate Tablet;Oral Lab Hra Pharma Manufacturing Change or Addition
Furosemide furosemide Injectable;Injection Luitpold Manufacturing Change or Addition
Gazyva obinutuzumab Injectable;Injection Genentech Labeling Revision
Lupron Depot leuprolide acetate Injectable;Injection Abbvie Endocrine Inc Labeling Revision
Lupron Depot leuprolide acetate Injectable;Injection Abbvie Endocrine Inc Labeling Revision
Oxymorphone Hydrochloride oxymorphone hydrochloride Tablet, Extended Release;Oral Mallinckrodt Inc Approval
Symlin pramlintide acetate Injectable;Subcutaneous Astrazeneca Ab Efficacy Supplement with Clinical Data to Support
Symlin pramlintide acetate Injectable;Subcutaneous Astrazeneca Ab Labeling Revision
Taxol paclitaxel Injectable;Injection Hq Spclt Pharma Manufacturing Change or Addition
Tribenzor amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil Tablet;Oral Daiichi Sankyo Labeling Revision
Vazculep phenylephrine hydrochloride Injectable; Injection Eclat Pharms Llc Approval
Virazole ribavirin For Solution;Inhalation Valeant Pharm Intl Manufacturing Change or Addition

 


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