What's New on the FDA Drugs Site
August 20, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA approves Cerdelga (eliglustat), new drug to treat a form of Gaucher disease
- FDA Drug Shortages: New and Updated
- Bupivacaine Hydrochloride (Marcaine, Sensorcaine) Injection (Currently in Shortage)
- Cefazolin Injection (Currently in Shortage)
- Clindamycin Phosphate (Cleocin) Injection (Currently in Shortage)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Epinephrine Injection (Currently in Shortage)
- Erythrocin Lactobionate Lyophilized Powder for Injection (Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage)
- Heparin Sodium Injection (Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Morphine Sulfate (Astramorph PF, Duramorph, Infumorph) Injection (Preservative Free) (Currently in Shortage)
- Nitroglycerin in 5% Dextrose Injection (Currently in Shortage)
- Ondansetron (Zofran) Injection (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Potassium Chloride Injection (Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Currently in Shortage)
- Sodium Phosphate Injection (Currently in Shortage)
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
August 19, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acyclovir | acyclovir | Tablet;Oral | Zydus Pharms Usa Inc | Approval |
| Ammonia N 13 | ammonia n 13 | Injectable;Injection | Johns Hopkins Univ | Approval |
| Avinza | morphine sulfate | Capsule, Extended Release;Oral | King Pharms Llc | Supplement |
| Butrans | buprenorphine | Film, Extended Release;Transdermal | Purdue Pharma Lp | Supplement |
| Cerdelga | eliglustat | Capsule; Oral | Genzyme Corp | Approval |
| Dolophine Hydrochloride | methadone hydrochloride | Syrup;Oral | Roxane | Supplement |
| Dolophine Hydrochloride | methadone hydrochloride | Tablet;Oral | Roxane | Supplement |
| Duragesic-100 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Supplement |
| Duragesic-12 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Supplement |
| Duragesic-25 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Supplement |
| Duragesic-50 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Supplement |
| Duragesic-75 | fentanyl | Film, Extended Release;Transdermal | Janssen Pharms | Supplement |
| Eliquis | apixaban | Tablet;Oral | Bristol Myers Squibb | Efficacy Supplement with Clinical Data to Support |
| Embeda | morphine sulfate; naltrexone hydrochloride | Capsule, Extended Release;Oral | Alpharma Pharms | Supplement |
| Exalgo | hydromorphone hydrochloride | Tablet, Extended Release;Oral | Mallinckrodt Inc | Supplement |
| Kadian | morphine sulfate | Capsule, Extended Release;Oral | Watson Labs Inc | Supplement |
| Ms Contin | morphine sulfate | Tablet, Extended Release;Oral | Purdue Pharma Lp | Supplement |
| Mycophenolic Acid | mycophenolic acid | Tablet, Delayed Release; Oral | Apotex Inc | Approval |
| Mycophenolic Acid | mycophenolic acid | Tablet, Delayed Release;Oral | Apotex Inc | Approval |
| Nucynta Er | tapentadol hydrochloride | Tablet, Extended Release;Oral | Janssen Pharms | Supplement |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release;Oral | Endo Pharms | Supplement |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release;Oral | Endo Pharms | Supplement |
| Oxycontin | oxycodone hydrochloride | Tablet, Extended Release;Oral | Purdue Pharma Lp | Supplement |
| Targiniq | naloxone hydrochloride; oxycodone hydrochloride | Tablet, Extended Release;Oral | Purdue Pharma Lp | Supplement |
| Zohydro Er | hydrocodone bitartrate | Capsule, Extended Release;Oral | Zogenix Inc | 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 |  |
