What's New on the FDA Drugs Site
June 20, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA and Marijuana
- FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment
- FDA Drug Shortages: New and Updated
- New Drug Shortage: Indigo Carmine Injection
- From a Clinical Perspective: FDA actions reduce drug shortages but critical issues remain
- National Drug Code Directory
New and Generic Drug Approvals
June 19, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Androderm | testosterone | Film, Extended Release;Transdermal | Watson Labs | Labeling Revision |
| Androgel | testosterone | Gel, Metered;Transdermal | Abbvie | Labeling Revision |
| Androgel | testosterone | Gel;Transdermal | Abbvie | Labeling Revision |
| Androgel | testosterone | Gel, Metered;Transdermal | Abbvie | Labeling Revision |
| Androgel | testosterone | Gel;Transdermal | Abbvie | Labeling Revision |
| Aveed | testosterone undecanoate | Injectable;Intramuscular | Endo Pharms Inc | Labeling Revision |
| Axiron | testosterone | Solution, Metered;Transdermal | Eli Lilly and Co | Labeling Revision |
| Bromfenac Sodium | bromfenac sodium | Solution/Drops;Ophthalmic | Apotex Inc | Approval |
| Combivent Respimat | albuterol sulfate; ipratropium bromide | Spray, Metered;Inhalation | Boehringer Ingelheim | Manufacturing Change or Addition |
| Delatestryl | testosterone enanthate | Injectable;Injection | Endo Pharms | Labeling Revision |
| Delsym | dextromethorphan polistirex | Suspension, Extended Release;Oral | Reckitt Benckiser | Labeling Revision |
| Depacon | valproate sodium | Injectable;Injection | Abbvie | Labeling Revision |
| Depakene | valproic acid | Capsule;Oral | Abbvie | Labeling Revision |
| Depakene | valproic acid | Syrup;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Tablet, Delayed Release;Oral | Abbvie | Labeling Revision |
| Depakote | divalproex sodium | Capsule, Delayed Rel Pellets;Oral | Abbvie | Labeling Revision |
| Depakote Er | divalproex sodium | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
| Fallback Solo | levonorgestrel | Tablet;Oral | Lupin Ltd | Approval |
| Fortesta | testosterone | Gel, Metered;Transdermal | Endo Pharms | Labeling Revision |
| Omnipaque 140 | iohexol | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 180 | iohexol | Solution;Injection, Oral, Rectal | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 210 | iohexol | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 240 | iohexol | Solution;Injection, Oral, Rectal | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 300 | iohexol | Solution;Injection, Oral, Rectal | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 350 | iohexol | Solution;Injection, Oral | Ge Healthcare | Manufacturing Change or Addition |
| Omnipaque 70 | iohexol | Solution;Urethral | Ge Healthcare | Manufacturing Change or Addition |
| Striant | testosterone | Tablet, Extended Release;Buccal | Auxilium Pharms Llc | Labeling Revision |
| Testim | testosterone | Gel;Transdermal | Auxilium Pharms | Labeling Revision |
| Testosterone | testosterone | Gel;Transdermal | Teva Pharms | Labeling Revision |
| Testosterone | testosterone | Gel, Metered;Transdermal | Perrigo Israel | Labeling Revision |
| Testosterone | testosterone | Gel;Transdermal | Perrigo Israel | Labeling Revision |
| Thalomid | thalidomide | Capsule;Oral | Celgene | Labeling Revision |
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