Enabling Swift and Safe Healthcare Worldwide

1. Final Approvals (2)
2. Rejections (1)
3. Orphan Drug Designations (5)
4. Recommended Approvals (0)
5. Fast Track Status (0)
6. Complete Response Letters (2)
7. Tentative Approvals (1)
8. Priority Reviews (1)
9. New Drug Applications (1)
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. Byetta Approved For Expanded Use As First-Line Treatment For Type 2 Diabetes
   Medical News Today
   
2. Covidien gets approval for generic pain drug Actiq
   Associated Press

2. Rejections

1. FDA won't accept Merck's application for new drug
   Associated Press

3. Orphan Drug Designations

1. Sunesis' Voreloxin Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia
   PR Newswire
   
2. GenVec's Pancreatic Cancer Treatment Assigned Orphan Drug Status
   RTT News
   
3. Araxane Receives Orphan Drug Status for the Treatment of Pancreatic Cancer and Stage IIB-IV Melanoma
   Business Wire
   
4. Zeltia's Nypta gets orphan drug status, shares gain
   Reuters
   
5. ImmuneWorks Receives Orphan Drug Designation
   Inside Indiana Business

6. Complete Response Letters

1. GTx Receives Complete Response Letter from FDA for Toremifene 80 mg New Drug Application
   Business Wire
   
2. Schering-Plough receives FDA complete response letter regarding Pegintron
   News-Medical.net

7. Tentative Approvals

1. Cadila gets FDA nod for Atomoxetine Hydrochloride capsules
   MyIris

8. Priority Reviews

1. Shire Gaucher drug gets FDA priority review
   Associated Press

9. New Drug Applications

1. InterMune Submits Application With FDA To Market Pirfenidone To Treat IPF
   RTT News

10. Alerts, Recalls and Shortages

1. ALERT: Byetta
   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