---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jul 2, 2014 at 5:24 AM
Subject: CDER New July 1, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Wed, Jul 2, 2014 at 5:24 AM
Subject: CDER New July 1, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 1, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA outlines expectations for human drug compounders, including registered outsourcing facilities
- Guidance for Industry:
- MedWatch Safety Alert: Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter
- National Drug Code Directory
- Postmarket Drug and Biologic Safety Evaluations (updated)
New and Generic Drug Approvals
July 1, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Afinitor | everolimus | Tablet;Oral | Novartis | Labeling Revision |
| Afinitor Disperz | everolimus | Tablet, For Suspension;Oral | Novartis Pharm | Labeling Revision |
| Epiduo | adapalene; benzoyl peroxide | Gel;Topical | Galderma Labs Lp | Manufacturing Change or Addition |
| Iprivask | desirudin recombinant | Injectable;Subcutaneous | Marathon Pharms Llc | Manufacturing Change or Addition |
| Linzess | linaclotide | Capsule;Oral | Forest Labs Inc | Manufacturing Change or Addition |
| Lithium Citrate | lithium citrate | Syrup;Oral | Roxane | Manufacturing Change or Addition |
| M.V.I. Adult | ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e; vitamin k | Injectable;Iv (Infusion) | Hospira | Manufacturing Change or Addition |
| Premphase 14/14 | estrogens, conjugated; medroxyprogesterone acetate | Tablet;Oral-28 | Wyeth Pharms Inc | Manufacturing Change or Addition |
| Prempro | estrogens, conjugated; medroxyprogesterone acetate | Tablet;Oral-28 | Wyeth Pharms Inc | Manufacturing Change or Addition |
June 30, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Argatroban | argatroban | Injectable;Injection | Par Sterile Products | Approval |
| Argatroban | argatroban | Injectable;Injection | Mylan Institutional | Approval |
| Butrans | buprenorphine | Film, Extended Release;Transdermal | Purdue Pharma Lp | Labeling Revision |
| Butrans | buprenorphine | Film, Extended Release;Transdermal | Purdue Pharma Lp | Manufacturing Change or Addition |
| Chloraprep One-Step | chlorhexidine gluconate; isopropyl alcohol | Sponge;Topical | Carefusion | Labeling Revision |
| Chloraprep One-Step Frepp | chlorhexidine gluconate; isopropyl alcohol | Sponge;Topical | Carefusion | Labeling Revision |
| Chloraprep One-Step Sepp | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Carefusion | Labeling Revision |
| Chloraprep Single Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Carefusion | Labeling Revision |
| Chloraprep Triple Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Carefusion | Labeling Revision |
| Chloraprep With Tint | chlorhexidine gluconate; isopropyl alcohol | Sponge;Topical | Carefusion | Labeling Revision |
| Faslodex | fulvestrant | Injectable;Intramuscular | Astrazeneca | Manufacturing Change or Addition |
| Herceptin | trastuzumab | Vial; Intravenous | Genentech | Labeling Revision |
| Hibiclens | chlorhexidine gluconate | Solution;Topical | Molnlycke Hlth | Labeling Revision |
| Myalept | metreleptin | Injectable;Injection | Amylin Pharms Llc | Labeling Revision |
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Jeremy Tobias Matthews
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