Fwd: CDER New June 27, 2014

---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, Jun 27, 2014 at 7:29 AM
Subject: CDER New June 27, 2014
To: iammejtm@gmail.com

What's New on the FDA Drugs Site

June 26, 2014

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Safety Oversight Board Meeting, Public Summary , May 15, 2014 
• FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning 
• FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots
• National Drug Code Directory
• Paragraph IV Patent Certifications (updated)
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
• Spanish FDA Drug Safety Communications
  • FDA advierte sobre reacciones poco frecuentes pero serias de hipersensibilidad a ciertos productos para el acné de uso tópico y venta libre
  • FDA advierte que el medicamento para el cáncer docetaxel puede causar síntomas de intoxicación alcohólica después del tratamiento

---

New and Generic Drug Approvals

June 25, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Cleocin Phosphate In Dextrose 5% In Plastic Container	clindamycin phosphate	Injectable;Injection	Pharmacia and Upjohn	Labeling Revision
Famvir	famciclovir	Tablet;Oral	Novartis	Manufacturing Change or Addition
Lisdexamfetamine Dimesylate	lisdexamfetamine dimesylate	Capsule;Oral	Amneal Pharms	Tentative Approval
Lisdexamfetamine Dimesylate	lisdexamfetamine dimesylate	Capsule;Oral	Mylan Pharms Inc	Tentative Approval

 

---

Subscriber Services:
Manage Preferences  |  Unsubscribe  |  Help with this service

Stay Connected:

---

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