---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jun 9, 2014 at 7:29 AM
Subject: CDER New June 9, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jun 9, 2014 at 7:29 AM
Subject: CDER New June 9, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
June 6, 2014
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (PDF - 95KB)
- National Drug Code Directory
- Pediatric Exclusivity Granted (updated)
- Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals
June 5, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Alsuma | sumatriptan succinate | Injectable;Subcutaneous | Meridian Medcl | Labeling Revision |
| Complera | emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate | Tablet;Oral | Gilead Sciences Inc | Labeling Revision |
| Exparel | bupivacaine | Injectable, Liposomal;Injection | Pacira Pharms Inc | Manufacturing Change or Addition |
| Fioricet W/ Codeine | acetaminophen; butalbital; caffeine; codeine phosphate | Capsule;Oral | Watson Labs Inc | Manufacturing Change or Addition |
| Invokana | canagliflozin | Tablet;Oral | Janssen Pharms | Manufacturing Change or Addition |
| Lioresal | baclofen | Injectable;Intrathecal | Medtronic Neuro | Manufacturing Change or Addition |
| Lovaza | omega-3-acid ethyl esters | Capsule;Oral | Smithkline Beecham | Manufacturing Change or Addition |
| Methoxsalen | methoxsalen | Capsule;Oral | Strides Arcolab Ltd | Approval |
| Oxycodone Hydrochloride | oxycodone hydrochloride | Solution;Oral | Coastal Pharms | Approval |
| Procardia Xl | nifedipine | Tablet, Extended Release;Oral | Pfizer | Manufacturing Change or Addition |
| Risperdal Consta | risperidone | Injectable;Intramuscular | Janssen Pharms | Manufacturing Change or Addition |
| Septocaine | articaine hydrochloride; epinephrine bitartrate | Injectable;Injection | Deproco | Manufacturing Change or Addition |
| Sodium Chloride 0.45% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Sodium Chloride 0.9% In Plastic Container | sodium chloride | Injectable;Injection | Baxter Hlthcare | Manufacturing Change or Addition |
| Suboxone | buprenorphine hydrochloride; naloxone hydrochloride | Film;Sublingual | Reckitt Benckiser | Manufacturing Change or Addition |
| Voltaren | diclofenac sodium | Tablet, Delayed Release;Oral | Novartis | Manufacturing Change or Addition |
| Voltaren-Xr | diclofenac sodium | Tablet, Extended Release;Oral | Novartis | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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