Pharmacy OneSource

Newsletter: Weekly FDA Review (5/3/2012) - Subscribe/Unsubscribe

Weekly FDA Review - 3.May.2012

Final Approvals (9)
Rejections (1)
Orphan Drug Designations (0)
Recommended Approvals (0)
Fast Track Status (0)
Complete Response Letters (0)
Tentative Approvals (0)
Priority Reviews (0)
New Drug Applications (3)
Alerts, Recalls and Shortages (2)

1. Final Approvals

FDA approves Glaxo cancer drug Votrient
Reuters
FDA approves Novartis drug for tumors in patients with rare genetic disease
Drug Store News
FDA approves pill Stendra
The Los Angeles Times
Levaquin Approved For Treating Plague, USA
Medical News Today
Orchid Pharma Gets FDA Nod For Olanzapine Tablets ANDA
RTT News
FDA approves Protalix's Gaucher drug Elelyso
Business Week
India's Dr Reddy's gets U.S. nod for osteoporosis drug
Reuters
FDA approves generic epilepsy drug from Acella
Drug Store News
FDA approves Meda allergy combo Dymista
Pharma Times

2. Rejections

FDA rejects Amgen's application for Xgeva
Reuters

9. New Drug Applications

Aegerion Pharmaceuticals Announces FDA Acceptance of New Drug Application for Review
Market Watch
Zogenix Submits NDA To FDA For Zohydro To Treat Chronic Pain
RTT News
Immunomic Therapeutics Receives IND Authorization
Market Watch

10. Alerts, Recalls and Shortages

SHORTAGE: Tromethamine Injection
FDA Notice
SHORTAGE: Epinephrine Injection
FDA Notice

E-mail This Newsletter to a Friend

PharmacyOneSource.com Privacy Policy
Pharmacy OneSource, 7780 Elmwood Ave. Ste #210 Middleton, WI 53562
Phone: (800) 654-8395

<< Back