What's New on the FDA Drugs Site
August 22, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Reviews (FDASIA) (updated)
- National Drug Code Directory
- Postmarketing Requirements and Commitments: Reports (updated)
- Public Notification: Ortiga Contains Hidden Drug Ingredient
- Spanish Drug Safety Communication: FDA requiere cambios en la etiqueta para advertir acerca del riesgo de daño neurológico potencialmente permanente por el uso de antibióticos con fluoroquinolona inyectados o de uso oral
New and Generic Drug Approvals
August 21, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Cefazolin and Dextrose | cefazolin sodium | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Crinone | progesterone | Gel; Vaginal | Watson Labs | Manufacturing Change or Addition |
| Dulera | formoterol fumarate; mometasone furoate | Aerosol, Metered; Inhalation | Merck Sharp Dohme | Labeling Revision |
| 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 |
| Humulin 70/30 | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin 70/30 Pen | insulin recombinant human; insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Humulin N | insulin susp isophane recombinant human | Injectable; Injection | Lilly | Manufacturing Change or Addition |
| Hydroxyzine Hydrochloride | hydroxyzine hydrochloride | Solution; Oral | Silarx Pharms Inc | Approval |
| Lysteda | tranexamic acid | Tablet; Oral | Ferring Pharms As | Labeling Revision |
| Natazia | dienogest; estradiol valerate | Tablet; Oral, Oral-28 | Bayer Hlthcare | 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 |
| Procalamine | amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride | Injectable; Injection | B Braun | Manufacturing Change or Addition |
| Rifampin | rifampin | Capsule; Oral | Lupin Pharms | Approval |
| Truvada | emtricitabine; tenofovir disoproxil fumarate | Tablet; Oral | Gilead | Manufacturing Change or Addition |
| Urso 250 | ursodiol | Tablet; Oral | Aptalis Pharma Us | Manufacturing Change or Addition |
| Urso Forte | ursodiol | Tablet; Oral | Aptalis Pharma Us | Manufacturing Change or Addition |
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