---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 3, 2014 at 6:43 AM
Subject: CDER New July 3, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 3, 2014 at 6:43 AM
Subject: CDER New July 3, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 2, 2014
- Approved Risk Evaluation and Mitigation Strategies (REMS) (Updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drugs@FDA Data Files (updated)
- FDA Drug Shortages: New and Updated
- National Drug Code Directory
- Pediatric Exclusivity Granted (updated)
- Spanish FDA Drug Safety Communications:
- La FDA recomienda no usar lidocaína para el tratamiento del dolor por dentición y requiere nuevo Recuadro de advertencia
- No es concluyente el análisis de la FDA de riesgos cardiovasculares para diabéticos que toman el medicamento para la hipertensión olmesartán; se requieren actualizaciones a la etiqueta
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 |
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Jeremy Tobias Matthews
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