What's New on the FDA Drugs Site
February 22, 2012
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
- Comunicado de la FDA sobre la seguridad de los medicamentos: Importantes interacciones entre el medicamento Victrelis (boceprevir) y los medicamentos inhibidores de la proteasa del virus de inmunodeficiencia humana (VIH) reforzados con ritonavir
- Drug Firm Annual Registration Status Download File (ZIP - 385KB)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Aminocaproic Acid (updated)
- Drug Shortages: Current Drug Shortages: Atropine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
- Drug Shortages: Current Drug Shortages: Bupivacaine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Butorphanol Injection (updated)
- Drug Shortages: Current Drug Shortages: Diltiazem Injection (updated)
- Drug Shortages: Current Drug Shortages: Etomidate Injection (updated)
- Drug Shortages: Current Drug Shortages: Furosemide Injection (updated)
- Drug Shortages: Current Drug Shortages: Levofloxacin Injection (updated)
- Drug Shortages: Current Drug Shortages: Lidocaine Hydrochloride Injection
- Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
- Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Mannitol Injection (updated)
- Drug Shortages: Current Drug Shortages: Methotrexate Injection (updated)
- Drug Shortages: Current Drug Shortages: Metoclopramide injection (updated)
- Drug Shortages: Current Drug Shortages: Midazolam Injection (updated)
- Drug Shortages: Current Drug Shortages: Morphine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Multi-Vitamin Infusion (Adult and pediatric) (updated)
- Drug Shortages: Current Drug Shortages: Naloxone
- Drug Shortages: Current Drug Shortages: Naltrexone Oral Tablet (updated)
- Drug Shortages: Current Drug Shortages: Ondansetron Injection 2 mg/mL (updated)
- Drug Shortages: Current Drug Shortages: Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII (updated)
- Drug Shortages: Current Drug Shortages: Orphenadrine Citrate Injection (updated)
- Drug Shortages: Current Drug Shortages: Sodium Phosphate Injection (updated)
- Drug Shortages: Current Drug Shortages: Tobramycin Solution for Injection (updated)
- Drug Shortages: Current Drug Shortages: Zinc Injection (updated)
- Drugs@FDA Download File (updated)
- Guidance for Industry: International Conference on Harmonisation - Quality: Q3C Maintenance Procedures Page (Updated)
- Q3C --Tables and List (Final Revised)
- PDE for Cumene (Final Recommendation)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Paragraph IV Patent Certifications (updated)
February 21, 2012
-
Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials
- Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
- Comunicado de la FDA sobre la seguridad de los medicamentos: La diarrea asociada con Clostridum difficile puede estar relacionada con los medicamentos contra la acidez estomacal denominados inhibidores de la bomba de protones (PPIs por sus siglas en inglés)
- Drug Firm Annual Registration Status Download File (ZIP - 385KB)
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Doxorubicin Liposomal (Doxil) Injection (updated)
- Drug Shortages: Current Drug Shortages: Mannitol Injection (updated)
- FDA acts to bolster supply of critically needed cancer drugs
- FDA approves Korlym (mifepristone) for patients with endogenous Cushing’s syndrome
- Generic Pharmaceutical Association 2011 Fall Technical Conference
- Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage (PDF - 225KB)
February 18, 2012
- Public Notification: “Hard Ten Days” Contains Undeclared Drug Ingredient
- Public Notification: “Man King” Contains Undeclared Drug Ingredient
- Public Notification: “Japan Weight Loss Blue” Contains Undeclared Drug Ingredient
New and Generic Drug Approvals
February 17, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atracurium Besylate | atracurium besylate | Injectable; Injection | Sagent Pharms | Approval |
| Atracurium Besylate | atracurium besylate | Injectable; Injection | Sagent Pharms | Approval |
| Cefaclor | cefaclor | Suspension; Oral | Yung Shin Pharm | Approval |
| Halaven | eribulin mesylate | Solution; Intravenous | Eisai Inc | Labeling Revision |
| Invanz | ertapenem sodium | Injectable; Intramuscular, Iv (Infusion) | Merck | Labeling Revision |
| Korlym | mifepristone | Tablet; Oral | Corcept Therapeutics | Approval |
| Losartan Potassium; Hydrochlorothiazide | losartan potassium; hydrochlorothiazide | Tablet; Oral | Alembic Pharms Ltd | Approval |
| Lupron Depot | leuprolide acetate | Injectable; Injection | Abbott Labs | Labeling Revision |
| Vaseretic | enalapril maleate; hydrochlorothiazide | Tablet; Oral | Valeant Intl | Labeling Revision |
| Vasotec | enalapril maleate | Tablet; Oral | Valeant Intl | Labeling Revision |
| This email was sent to clotito+biotechdash@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
No comments:
Post a Comment