What's New on the FDA Drugs Site
August 1, 2014
- Manual of Policies and Procedures (MAPP) 5016.4 Clarification Teleconferences Between Sponsors, Applicants, or Master File Holders And the ONDQA Review Team (PDF - 164KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Calcium Gluconate Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Cyanocobalamin (Vitamin B12) Injection (Currently in Shortage)
- Dexamethasone Sodium Phosphate Injection (Currently in Shortage)
- Haloperidol Lactate Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Magnesium Sulfate Injection (Currently in Shortage)
- Phosphate (Glycophos) Injection (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sodium Chloride 23.4% Injection (Currently in Shortage)
- Tobramycin Solution for Injection (Currently in Shortage)
-
- FDA expands approval of Lumizyme (alglucosidase alfa) to treat Pompe disease in patients of all ages; removes risk mitigation strategy requirements
- National Drug Code Directory
- Patient-Focused Drug Development Public Meeting and Scientific workshop on Female Sexual Dysfunction, October 27-28, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. 20993. Meeting information
New and Generic Drug Approvals
July 31, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adrenalin | epinephrine | Injectable;Intramuscular, Intraocular, Subcutaneous | Par Sterile Products | Manufacturing Change or Addition |
| Estradiol | estradiol | Film, Extended Release; Transdermal | Novartis | Labeling Revision |
| Farxiga | dapagliflozin | Tablet;Oral | Astrazeneca Ab | Manufacturing Change or Addition |
| Fortesta | testosterone | Gel, Metered;Transdermal | Endo Pharms | Supplement |
| Gilotrif | afatinib dimaleate | Tablet;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Hectorol | doxercalciferol | Injectable;Injection | Genzyme Corp | Manufacturing Change or Addition |
| Humalog | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Kwikpen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Humalog Pen | insulin lispro recombinant | Injectable;Injection | Lilly | Manufacturing Change or Addition |
| Loestrin Fe 1/20 | ethinyl estradiol; norethindrone acetate | Tablet;Oral-28 | Warner Chilcott | Manufacturing Change or Addition |
| Megace Es | megestrol acetate | Suspension;Oral | Par Pharm | Manufacturing Change or Addition |
| Pegintron | peginterferon alfa-2b | Syringe | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Somavert | pegvisomant | Injectable;Subcutaneous | Pharmacia and Upjohn | Manufacturing Change or Addition |
| Striverdi Respimat | olodaterol respimat | Spray;Metered | Boehringer Ingelheim | Approval |
| Sylatron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Victoza | liraglutide recombinant | Solution;Subcutaneous | Novo Nordisk Inc | Labeling Revision |
| Vivelle-Dot | estradiol | Film, Extended Release;Transdermal | Novartis | Labeling Revision |
| Zanosar | streptozocin | Injectable;Injection | Teva Pharms Usa | Manufacturing Change or Addition |
| Zelapar | selegiline hydrochloride | Tablet, Orally Disintegrating;Oral | Valeant Pharm Intl | Labeling Revision |
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
