CDER New April 10,2014

FDA (U.S. Food and Drug Administration)

April 9, 2014

  • Public Workshop: Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction. June 9, 2014, FDA White Oak Campus, Bldg. 31, Great Room 1503, Silver Spring, MD.  Meeting Information
  • Current Drug Shortages Index (updated)

What's New on the FDA Drugs Site

Date

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New and Generic Drug Approvals

April 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Augmentin Es-600 amoxicillin; clavulanate potassium For Suspension;Oral Dr Reddys Labs Inc Manufacturing Change or Addition
Isentress raltegravir potassium Tablet;Oral Merck Sharp Dohme Labeling Revision
Isentress raltegravir potassium Tablet, Chewable;Oral Merck Sharp Dohme Labeling Revision
Isentress raltegravir potassium Powder;Oral Merck Sharp Dohme Labeling Revision
Kalydeco ivacaftor Tablet;Oral Vertex Pharms Labeling Revision
Ortho-Cept desogestrel; ethinyl estradiol Tablet;Oral-21 Janssen Pharms Manufacturing Change or Addition
Ortho-Cept desogestrel; ethinyl estradiol Tablet;Oral-28 Janssen Pharms Manufacturing Change or Addition
Oxaliplatin oxaliplatin Injectable;Injection Sun Pharma Global Approval
Oxaliplatin oxaliplatin Injectable;Injection Sun Pharma Global Tentative Approval
Synthroid levothyroxine sodium Tablet;Oral Abbvie Manufacturing Change or Addition

 


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