Calendar

 


Month: Year:
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* CORT PDUFACORT PDUFA

Corlux in Cushing's Syndrome
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* CBRX PDUFACBRX PDUFA

NDA decision date for PROCHIEVE® Vaginal Progesterone Gel for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.
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Calendar developed and supported by Kieran O'Shea

 


3Q 2011 Events:

ALXA – Resubmit NDA for Staccato loxepine (schizophrenia)
AMRN – NDA submission for AMR101 (elevated triglycerides)
BDSI – Phase III data for BEMA buprenoprphine (pain)
BPAX – Phase III data for Libigel (female hypoactive sexual desire disorder) – Fall 2011
CHTP - NDA submission for Northera (nuerogenic orthostatic hypotension)
CLSN - Phase III interim data for ThermoDox in primary liver cancer
DSCOD - Refile NDA for Surfaxin LS (respiratory distress syndrome)
IRWD –  NDA submission for linaclotide (irritable bowel syndrome w/ constipation, chronic constipation)
ONXX – Rolling NDA submission for carfilzomib (refractory multiple myeloma)
VRTX - Phase II data for JAK3 inhibitor expected in September
ZGNX – Phase III data for ZX002 (moderate to severe pain)

4Q 2011 Events:

DEPO – Phase III data for Serada (menopausal hot flashes)
DCTH - NDA resubmission (post-refusal to file letter) for chemosaturation system (metastatic melanoma)
DVAX –  BLA filing for HEPLISAV (hepatitis B)
SGMO - Phase II data for SB-509 (diabetic neuropathy)
VRTX- NDA and MAA filing for VX-770 in Cystic Fibrosis by October

2H 2011 Events:

SGMO - Phase I/II data for SB-728-T (HIV/AIDS)

1Q 2012 Events:

TSRX - Phase III data for Torezolid Phosphate (ABSSSI)