CDER New May 18, 2015

What's New on the FDA Drugs Site

May 15, 2015

• FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood 
• FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs 
• From our perspective: The U.S. drug supply chain and patient safety
• Drug Trials Snapshot: Corlanor
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Orange Book (updated)
  • April 2015: Additions and Deletions to the Drug Product List (PDF - 186KB)
  • Orange Book Current Cumulative Supplement (PDF - 940KB)
  • Orange Book Data Files (compressed) (ZIP - 600KB)
• National Drug Code Directory

---

New and Generic Drug Approvals

May 14, 2015

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Bactroban	mupirocin calcium	Ointment;Nasal	Glaxosmithkline	Labeling Revision
Escitalopram Oxalate	escitalopram oxalate	Tablet; Oral	Mylan Pharma	Approval
Famvir	famciclovir	Tablet;Oral	Novartis	Manufacturing Change or Addition
Gilenya	fingolimod	Capsule;Oral	Novartis	Supplement
Isovue-128	iopamidol	Injectable;Injection	Bracco	Manufacturing Change or Addition
Isovue-200	iopamidol	Injectable;Injection	Bracco	Manufacturing Change or Addition
Isovue-250	iopamidol	Injectable;Injection	Bracco	Manufacturing Change or Addition
Isovue-300	iopamidol	Injectable;Injection	Bracco	Manufacturing Change or Addition
Isovue-370	iopamidol	Injectable;Injection	Bracco	Manufacturing Change or Addition
Isovue-M 200	iopamidol	Injectable;Injection	Bracco	Manufacturing Change or Addition
Isovue-M 300	iopamidol	Injectable;Injection	Bracco	Manufacturing Change or Addition
Lamivudine; Zidovudine	lamivudine; zidovudine	Tablet; Oral Suspension	Mylan Labs	Manufacturing Change or Addition
Paricalcitol	paricalcitol	Solution;Intravenous	Hospira Inc	Manufacturing Change or Addition
Rufinamide	rufinamide	Tablet;Oral	Glenmark Generics	Tentative Approval
Sirturo	bedaquiline fumarate	Tablet;Oral	Janssen Therap	Labeling Revision
Treximet	naproxen sodium; sumatriptan succinate	Tablet;Oral	Pernix Ireland Ltd	Efficacy Supplement with Clinical Data to Support
Treximet	naproxen sodium; sumatriptan succinate	Tablet;Oral	Pernix Ireland Ltd	Labeling Revision

 

---

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

Stay Connected:

---

This email was sent to rssproject471@gmail.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420

Tweet

Postingan terkait:

— Monday, May 18, 2015 — Add Comment