What's New on the FDA Drugs Site
August 12, 2015
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Safety Podcast: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs
- FDA Drug Shortages
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Cefazolin Injection (Updated - Currently in Shortage)
- Cefotetan Disodium Injection (Updated - Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
- Haloperidol Lactate Injection (Updated - Currently in Shortage)
- Imipenem and Cilastatin for Injection, USP (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Vancomycin Hydrochloride for Injection, USP (Updated - Currently in Shortage)
- National Drug Code Directory
- Pharmacologic Class (updated)
New and Generic Drug Approvals
August 11, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Botox | onabotulinumtoxina | Vial; Single-Use | Allergan | Labeling Revision |
| Botox Cosmetic | onabotulinumtoxina | Vial; Single-Use | Allergan | Labeling Revision |
| Breo Ellipta | fluticasone furoate; vilanterol trifenatate | Powder;Inhalation | Glaxo Grp Ltd | Manufacturing Change or Addition |
| Brovana | arformoterol tartrate | Solution;Inhalation | Sunovion | Manufacturing Change or Addition |
| Copegus | ribavirin | Tablet;Oral | Roche | Labeling Revision |
| Delestrogen | estradiol valerate | Injectable;Injection | Par Sterile Products | Manufacturing Change or Addition |
| Helidac | bismuth subsalicylate; metronidazole; tetracycline hydrochloride | Tablet, Chewable, Tablet, Capsule;Oral | Prometheus Labs | Labeling Revision |
| Lazanda | fentanyl citrate | Spray, Metered;Nasal | Depomed Inc | Manufacturing Change or Addition |
| Onsolis | fentanyl citrate | Film;Buccal | Biodelivery Sci Intl | Manufacturing Change or Addition |
| Sivextro | tedizolid phosphate | Tablet;Oral | Cubist Pharms Inc | Manufacturing Change or Addition |
| Zelboraf | vemurafenib | Tablet;Oral | Hoffmann La Roche | Labeling Revision |
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Thursday, August 13, 2015
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