What's New on the FDA Drugs Site
August 15, 2014
- FDA Drug Shortages: New and Updated
- Famotidine Injection (Currently in Shortage)
- FDA’s GDUFA Public Hearing on Policy Development, September 17, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Avastin (bevacizumab) to treat patients with aggressive and late-stage cervical cancer
- From a Clinical Perspective: What is the Generic Drug User Fee Amendments (GDUFA) of 2012 regulatory science program?
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
August 14, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Avastin | bevacizumab | Vial; Intravenous | Genentech | Efficacy Supplement with Clinical Data to Support |
| Colcrys | colchicine | Tablet;Oral | Takeda Pharms Usa | Labeling Revision |
| Combivent Respimat | albuterol sulfate; ipratropium bromide | Spray, Metered;Inhalation | Boehringer Ingelheim | Manufacturing Change or Addition |
| Commit | nicotine polacrilex | Troche/Lozenge;Oral | Glaxosmithkline Cons | Labeling Revision |
| Decitabine | decitabine | Powder;Intravenous | Sun Pharma Global | Manufacturing Change or Addition |
| Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate | efavirenz;lamivudine;tenofovir disoproxil fumarate | Tablet;Oral | Macleods Pharms Ltd | Tentative Approval |
| Lotensin Hct | benazepril hydrochloride; hydrochlorothiazide | Tablet;Oral | Us Pharms Holdings I | Manufacturing Change or Addition |
| Metopirone | metyrapone | Capsule;Oral | Hra Pharma | Manufacturing Change or Addition |
| Metopirone | metyrapone | Tablet;Oral | Hra Pharma | Manufacturing Change or Addition |
| Migranal | dihydroergotamine mesylate | Spray, Metered;Nasal | Valeant | Manufacturing Change or Addition |
| Pegintron | peginterferon alfa-2b | Syringe | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Pradaxa | dabigatran etexilate mesylate | Capsule;Oral | Boehringer Ingelheim | Labeling Revision |
| Sustiva | efavirenz | Capsule;Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Sustiva | efavirenz | Tablet;Oral | Bristol Myers Squibb | Manufacturing Change or Addition |
| Sylatron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Vascepa | icosapent ethyl | Capsule;Oral | Amarin Pharms | Manufacturing Change or Addition |
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