Enabling Swift and Safe Healthcare Worldwide

1. Final Approvals (6)
2. Rejections (0)
3. Orphan Drug Designations (2)
4. Recommended Approvals (0)
5. Fast Track Status (0)
6. Complete Response Letters (0)
7. Tentative Approvals (0)
8. Priority Reviews (0)
9. New Drug Applications (3)
10. Alerts, Recalls and Shortages (1)

---

Sentri7 monitors anticoagulation patients to help you comply with The Joint Commission's NPSG 3E. Get a demo.

---

1. Final Approvals

1. Glaxo wins U.S. approval for swine flu vaccine
   Reuters
   
2. Teva Receives Final Approval For Generic Prevacid Delayed-Release Capsules
   Medical News Today
   
3. Mylan Receives FDA Approval For Generic Version Of Prevacid Through Its Subsidiary Matrix Laboratories
   Medical News Today
   
4. Aurobindo gets FDA nod for hypertension drug
   Business Standard
   
5. FDA Approves Gloucester Pharmaceuticals' Istodax For Patients With Cutaneous T-cell Lymphoma
   Medical News Today
   
6. FDA Approves Pennsaid Topical Solution
   Reuters

3. Orphan Drug Designations

1. Ikano Therapeutics Receives Orphan Drug Designation for Epilepsy Drug
   Business Wire
   
2. Daval International Awarded Orphan Drug Designation for Motor Neurone Disease Treatment
   PharmiWeb

9. New Drug Applications

1. ChemGenex's NDA for leukemia drug accepted for review by FDA
   Trading Markets
   
2. Cequent files first IND application
   Mass High Tech
   
3. Sol-Gel’s IND Application for Rosacea Accepted by FDA
   Business Wire

10. Alerts, Recalls and Shortages

1. RECALL: Propofol & Liposyn
   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