What's New on the FDA Drugs Site
April 16, 2013
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Actions on OxyContin Products (4/16/2013)
- FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall
- MedWatch Safety Alert: Sterile Products Compounded, Repackaged, and Distributed by ApothéCure: Recall - Sterility Assurance Concerns
- MedWatch Safety Alert: Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns
- National Drug Code Directory (updated)
New and Generic Drug Approvals
April 15, 2013
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acetaminophen and Codeine Phosphate | acetaminophen; codeine phosphate | Tablet; Oral | Aurolife Pharma Llc | Approval |
| Alsuma | sumatriptan succinate | Injectable; Subcutaneous | Meridian Medcl | Manufacturing Change or Addition |
| Avinza | morphine sulfate | Capsule, Extended Release; Oral | King Pfizer | Labeling Revision |
| Butrans | buprenorphine | Film, Extended Release; Transdermal | Purdue Pharma Lp | Labeling Revision |
| Curosurf | poractant alfa | Suspension; Intratracheal | Cornerstone Therap | Manufacturing Change or Addition |
| Dolophine Hydrochloride | methadone hydrochloride | Syrup; Oral | Roxane | Labeling Revision |
| Dolophine Hydrochloride | methadone hydrochloride | Tablet; Oral | Roxane | Labeling Revision |
| Doribax | doripenem | Injectable; Iv (Infusion) | Janssen Pharms | Labeling Revision |
| Duragesic-100 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-12 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-25 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-50 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Labeling Revision |
| Duragesic-75 | fentanyl | Film, Extended Release; Transdermal | Janssen Pharms | Labeling Revision |
| Dutasteride | dutasteride | Capsule; Oral | Roxane | Tentative Approval |
| Dutasteride | dutasteride | Capsule; Oral | Sandoz Inc | Tentative Approval |
| Embeda | morphine sulfate; naltrexone hydrochloride | Capsule, Extended Release; Oral | Alpharma King | Labeling Revision |
| Exalgo | hydromorphone hydrochloride | Tablet, Extended Release; Oral | Mallinckrodt Inc | Labeling Revision |
| Inspra | eplerenone | Tablet; Oral | Gd Searle Llc | Manufacturing Change or Addition |
| Kadian | morphine sulfate | Capsule, Extended Release; Oral | Actavis Elizabeth | Labeling Revision |
| Ms Contin | morphine sulfate | Tablet, Extended Release; Oral | Purdue Pharma Lp | Labeling Revision |
| Nucynta Er | tapentadol hydrochloride | Tablet, Extended Release; Oral | Janssen Pharms | Labeling Revision |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release; Oral | Endo Pharms | Labeling Revision |
| Opana Er | oxymorphone hydrochloride | Tablet, Extended Release; Oral | Endo Pharms | Labeling Revision |
| Oxycontin | oxycodone hydrochloride | Tablet, Extended Release; Oral | Purdue Pharma Lp | Labeling Revision |
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