What's New on the FDA Drugs Site
June 26, 2012
- Drug Firm Annual Registration Status Download File
- Drug Firm Annual Registration Status (updated)
- FDA Drug Safety Communication: Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairment
- FDA Drug Safety Podcast for Healthcare Professionals: Cefepime and risk of seizure in patients not receiving dosage adjustments for kidney impairment
- Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
- Drug Shortages: Current Drug Shortages: Alfentanil Injection (updated)
- Drug Shortages: Current Drug Shortages: Amino Acid Products (updated)
- Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Aquasol A (updated)
- Drug Shortages: Current Drug Shortages: Atropine Sulfate Injection (updated)
- Drug Shortages: Current Drug Shortages: Bumetanide Injection (updated)
- Drug Shortages: Current Drug Shortages: Bupivacaine Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Buprenorphine Injection (updated)
- Drug Shortages: Current Drug Shortages: Chromic Chloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Diltiazem Injection (updated)
- Drug Shortages: Current Drug Shortages: Epinephrine Injection (updated)
- Drug Shortages: Current Drug Shortages: Epinephrine 1mg/mL (Preservative Free) (updated)
- Drug Shortages: Current Drug Shortages: Etomidate Injection (updated)
- Drug Shortages: Current Drug Shortages: Fentanyl Citrate Injection (updated)
- Drug Shortages: Current Drug Shortages: Fosphenytoin Sodium Injection (updated)
- Drug Shortages: Current Drug Shortages: Hydromorphone Hydrochloride Injection (updated)
- Drug Shortages: Current Drug Shortages: Intravenous Fat Emulsion (updated)
- Drug Shortages: Current Drug Shortages: Ketorolac Injection (updated)
- Drug Shortages: Current Drug Shortages: Lidocaine Hydrochloride Injection (updated)
- 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: 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: Morphine Sulfate Injection (Preservative Free) (updated)
- Drug Shortages: Current Drug Shortages: Nalbuphine HCl Injection (updated)
- Drug Shortages: Current Drug Shortages: Naloxone Injection (updated)
- Drug Shortages: Current Drug Shortages: Ondansetron Injection 32 mg/50 mL premixed bags (updated)
- Drug Shortages: Current Drug Shortages: Oxytocin Injection, USP (synthetic) (updated)
- Drug Shortages: Current Drug Shortages: Pancuronium Bromide Injection (updated)
- Drug Shortages: Current Drug Shortages: Phytonadione Injectable Emulsion (Vitamin K) (updated)
- Drug Shortages: Current Drug Shortages: Potassium Chloride Injection 2 mEq/mL (updated)
- Drug Shortages: Current Drug Shortages: Potassium Phosphate Injection (updated)
- Drug Shortages: Current Drug Shortages: Procainamide HCL Injection (updated)
- Drug Shortages: Current Drug Shortages: Promethazine Injection (updated)
- Drug Shortages: Current Drug Shortages: Protonix (pantoprazole) Injection (updated)
- Drug Shortages: Current Drug Shortages: Sodium Bicarbonate Injection (updated)
- Drug Shortages: Current Drug Shortages: Sufentanil Citrate Injection (updated)
- Drug Shortages: Current Drug Shortages: Tobramycin Solution for Injection (updated)
- Drug Shortages: Current Drug Shortages: Tromethamine Injection (updated)
- Drug Shortages: Current Drug Shortages: Vecuronium Injection (updated)
- Drug Shortages: Current Drug Shortages: Zinc Injection (updated)
- Drug Shortages: Drugs to be Discontinued: Mytelase (Ambenonium Chloride)
- National Drug Code Directory (updated)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
June 25, 2012
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Methergine | methylergonovine maleate | Injectable; Injection | Novartis | Approval |
| Methergine | methylergonovine maleate | Tablet; Oral | Novartis | Approval |
| Norgestimate and Ethinyl Estradiol | ethinyl estradiol; norgestimate | Tablet; Oral | Lupin Pharms | Approval |
| Thiamine Hydrochloride | thiamine hydrochloride | Injectable; Injection | Mylan Institutional | Approval |
| Trokendi Xr | topiramate | Capsule, Extended Release; Oral | Supernus Pharmaceuticals Inc. | Tentative Approval |
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