What's New on the FDA Drugs Site
September 27, 2013
- Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (CFS and ME) Stakeholder Teleconference – October 16, 2013
- FDA Drug Safety Communication: FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning
- FDA alerts patients and health care providers not to use budesonide solution from The Compounding Shop
New and Generic Drug Approvals
September 26, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Mestinon | pyridostigmine bromide | Syrup;Oral | Valeant Pharm Intl | Manufacturing Change or Addition |
| Pur-Wash | purified water | Solution;Ophthalmic | Niagara Pharms | Manufacturing Change or Addition |
| Remodulin | treprostinil | Injectable;Iv (Infusion)-Sc | United Therap | Labeling Revision |
| Somavert | pegvisomant | Injectable;Subcutaneous | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Terazol 3 | terconazole | Suppository;Vaginal | Janssen Pharms | Labeling Revision |
| Terazol 3 | terconazole | Cream;Vaginal | Janssen Pharms | Labeling Revision |
| Terazol 7 | terconazole | Cream;Vaginal | Janssen Pharms | Labeling Revision |
| Tobi | tobramycin | Solution;Inhalation | Novartis Pharms | Labeling Revision |
| Tygacil | tigecycline | Injectable;Iv (Infusion) | Pf Prism Cv | Labeling Revision |
| Vyfemla | ethinyl estradiol; norethindrone | Tablet;Oral-28 | Lupin Ltd | Approval |
| Zoloft | sertraline hydrochloride | Tablet;Oral | Pfizer | Manufacturing Change or Addition |
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