Company | Ticker | Compound | Indication | PDUFA date |
Alnara Pharmaceuticals (Eli Lilly) | LLY | Liprotamase | Treatment of exocrine pancreatic insufficiency | Early 2011 |
Spectrum Pharmaceuticals | SPPI | Fusilev (levoleucovorin) | Advanced metastatic colorectal cancer | 4/29/2011 |
Eisai Pfizer |
Tokyo:4523 PFE |
Aricept donepezil transdermal patch | Alzheimer's disease | 4/30/2011 |
EUSA Pharma | Private | Erwinase (L-asparaginase derived from Erwinia chrysanthemi) | Acute lymphoblastic leukemia | 5/3/2011 |
Vertex Pharmaceuticals Johnson & Johnson Mitsubishi Tanabe Pharma |
VRTX NYSE:JNJ Tokyo:4508; Osaka:4508 |
Telaprevir | Treatment for people with genotype 1 chronic hepatitis | 5/23/2011 |
Optimer Astellas |
OPTR | Dificid (fidaxomicin) | Clostridium difficile infection | 5/30/2011 |
Bristol-Myers Squibb | BMY | Belatacept (LEA29Y) | Prevent of organ rejection in kidney transplant recipients | 6/15/2011 |
Pain Therapeutics Pfizer |
PTIE PFE |
Remoxy (oxycodone) | Pain Reliever | 6/23/2011 |
Transcept | TSPT | Intermezzo | Sleep Disorder | 7/14/2011 |
AstraZeneca | AZN | Brilinta (ticagrelor) | Treatment of acute coronary syndromes | 7/20/2011 |
Pacira Pharmaceuticals | PCRX | Exparel (depobupivacaine) | Post-surgical pain management | 7/28/2011 |
Acura Pharmaceuticals Pfizer |
ACUR NYSE:PFE |
Acurox oxycodone | Moderate to severe pain | 6/17/2011 |
April 25, 2011
http://www.burrillreport.com/article-upcoming_pdufa_dates.html