---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 3, 2014 at 6:32 AM
Subject: CDER New July 2, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Thu, Jul 3, 2014 at 6:32 AM
Subject: CDER New July 2, 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 2, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Azor | amlodipine besylate; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Bendamustine Hydrochloride Injection | bendamustine hydrochloride | Injectable; Injection | Eagle Pharms | Tentative Approval |
| Letairis | ambrisentan | Tablet;Oral | Gilead | Manufacturing Change or Addition |
| Norpramin | desipramine hydrochloride | Tablet;Oral | Sanofi Aventis Us | Labeling Revision |
| Qualaquin | quinine sulfate | Capsule;Oral | Mutual Pharm Co Inc | Labeling Revision |
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 |
| This email was sent to iammejtm@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
Jeremy Tobias Matthews
No comments:
Post a Comment