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From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jul 14, 2014 at 8:30 AM
Subject: CDER New July 14, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jul 14, 2014 at 8:30 AM
Subject: CDER New July 14, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 11, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA alerts health care professionals not to use sterile drugs from Unique Pharmaceuticals
- FDA Drug Shortages: New and Updated
- Cefazolin Injection (Currently in Shortage)
- Dextrose 5% Injection Bags (Currently in Shortage)
- Methylphenidate Hydrochloride ER Capsules/Tablets (Currently in Shortage)
- Methylphenidate Hydrochloride Tablets (Currently in Shortage)
- Methylprednisolone Sodium Succinate Injection (Currently in Shortage)
- Multi-Vitamin Infusion (Adult and Pediatric) (Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Currently in Shortage)
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- First-Time Generic Drug Approvals - June 2014
- MedWatch: Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination
- National Drug Code Directory
- Social Media Guidance Webinar – July 10, 2014 (updated)
New and Generic Drug Approvals
July 10, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Anafranil | clomipramine hydrochloride | Capsule;Oral | Mallinckrodt Llc | Labeling Revision |
| Docetaxel | docetaxel | Injectable;Injection | Hospira Inc | Efficacy Supplement with Clinical Data to Support |
| Namenda | memantine hydrochloride | Solution;Oral | Forest Labs | Manufacturing Change or Addition |
| Pamelor | nortriptyline hydrochloride | Solution;Oral | Mallinckrodt Inc | Labeling Revision |
| Pamelor | nortriptyline hydrochloride | Capsule;Oral | Mallinckrodt Llc | Labeling Revision |
| Pennsaid | diclofenac sodium | Solution;Topical | Mallinckrodt Inc | Manufacturing Change or Addition |
| Qnasl | beclomethasone dipropionate | Aerosol, Metered;Nasal | Teva Branded Pharm | Labeling Revision |
| Rasuvo | methotrexate | Injectable;Injection | Medac Pharma Inc | Approval |
| Rescula | unoprostone isopropyl | Solution/Drops;Ophthalmic | Sucampo Pharms | Manufacturing Change or Addition |
| Tofranil-Pm | imipramine pamoate | Capsule;Oral | Mallinckrodt Inc | Labeling Revision |
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Jeremy Tobias Matthews
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