What's New on the FDA Drugs Site
June 6, 2012
- CDER Director's Mailbag: Have a question about what we do at CDER?
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Atropine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Calcium Chloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Dextrose Injection (updated)
- Drug Shortages: Current Drug Shortages: Doxorubicin Solution for Injection (updated)
- Drug Shortages: Current Drug Shortages: Epinephrine Injection (updated)
- Drug Shortages: Current Drug Shortages: Fluorouracil Injection (updated)
- Drug Shortages: Current Drug Shortages: Lidocaine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Morphine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Naloxone Injection (updated)
- Drug Shortages: Current Drug Shortages: Phytonadione Injectable Emulsion (Vitamin K) (updated)
- Drug Shortages: Current Drug Shortages: Sodium Bicarbonate Injection (updated)
- Drug Shortages: Current Drug Shortages: Sulfamethoxazole 80mg/trimethoprime 16mg/ml Injection (SMX/TMPP) (updated)
- Drug Shortages: Drugs to be Discontinued: Betamethasone Oral Solution
- Drug Shortages: Drugs to be Discontinued: Chromitope Sodium (Sodium Chromate Cr 51 Injection USP)
- Drug Shortages: Resolved Drug Shortage: AsmanexTwisthaler 110 mcg (Mometasone Furoate Inhalation Powder)
- Drug Shortages: Resolved Drug Shortages: Fabrazyme (agalsidase beta) (updated)
- Drugs@FDA Download File (updated)
- Guidance for Industry: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (PDF - 428KB)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- Webinar: Practical Advice for Preventing Surgical Fires--Safety Strategies from the Front Lines (updated)
June 5, 2012
- Warning Letters 2012 (updated)
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Atropine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Digoxin Injection (updated)
- Drug Shortages: Current Drug Shortages: Diltiazem Injection (updated)
- Drug Shortages: Current Drug Shortages: Diphenhydramine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Hydromorphone Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Morphine Sulfate Injection (Preservative Free) (updated)
- Drug Shortages: Current Drug Shortages: Ondansetron Injection 2 mg/mL (updated)
- Drug Shortages: Current Drug Shortages: Sufentanil Injection (updated)
- Medication Guides (updated)
- Pediatric Statistics: Pediatric Exclusivity Granted (updated)
June 4, 2012
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
- Drug Shortages: Current Drug Shortages: Calcitriol 1 mcg/mL Injection (updated)
- Drug Shortages: Current Drug Shortages: Lidocaine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Mitomycin Powder for Injection (updated)
- Drug Shortages: Current Drug Shortages: Naltrexone Oral Tablets (updated)
- Drug Shortages: Current Drug Shortages: Phentolamine Mesylate (updated)
- Drug Shortages: Current Drug Shortages: Neupro (rotigotine transdermal system) (updated)
- Drug Shortages: Current Drug Shortages: Vasopressin Injection (updated)
- Drug Shortages: Drugs to be Discontinued: Luveris (lutropin alfa for injection)
- Drug Shortages: Resolved Drug Shortages: Insulin glulisine [rDNA origin] injection solution
- National Drug Code Directory (updated)
New and Generic Drug Approvals
June 5, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Abstral | fentanyl citrate | Tablet; Sublingual | Prostrakan Inc | Labeling Revision |
| Actiq | fentanyl citrate | Troche/Lozenge; Transmucosal | Cephalon | Labeling Revision |
| Fentora | fentanyl citrate | Tablet; Buccal | Cephalon | Labeling Revision |
| Lazanda | fentanyl citrate | Spray, Metered; Nasal | Archimedes | Labeling Revision |
| Onsolis | fentanyl citrate | Film; Buccal | Meda Pharms | Labeling Revision |
| Proventil-Hfa | albuterol sulfate | Aerosol, Metered; Inhalation | 3m | Labeling Revision |
| Subsys | fentanyl | Spray; Sublingual | Insys Therap | Labeling Revision |
June 4, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alimta | pemetrexed disodium | Injectable; Iv (Infusion) | Lilly | Labeling Revision |
| Intron A | interferon alfa-2b | Vial | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Syringe | Schering | Labeling Revision |
| Pegintron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
| Sylatron | peginterferon alfa-2b | Vial | Schering | Labeling Revision |
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