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Sunday, March 10, 2013

Upcoming FDA approval for March 2013: ZGNX, THRX, GSK, BMY, AEZS, ARIA, ZIOP, INO, ALIM

03/01/2013: ZGNX    PDUFA for Zohydro ER got delayed

03/7/2013:  THRX    FDA advisory committee delayed  decision.

03/07/2013: GSK  FDA Panel to review BREO ELLIPTA for long term maintenance treatement of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease.

03/17/2013: BMY : FDA decision on Eliquis to reduce risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

03/18/2013: BLRX   DMC will provide estimate of total number of required for study of phase 2 drug.

03/21/2013:  TTNP.OB   FDA panel to review probuphine for the maintenance treatment of adult patients with opioid dependence.

03/27/2013:  ARIA FDA decision on Ponatinib for patients with resistant or intolerant chronic myeloid leukemia.

03/28/2013: ZIOP  Phase 3 data.

03/27/2013:  APPA.OB    FDA Decision on APF530 for prevention of acute and delayed onset chemotherapy induced nausea and vomiting.

03/30/2013: EXAS   Phase 3 data for DeeP-C pivotal trial of Cologuard for colorectal cancer.

03/31/2013:  UTHR  FDA decision on oral Treprostinil for treatment of pulmonary arterial hypertension.

03/31/2013: JNJ  FDA decision on INVOKANA for treatment of type 2 diabetes in adult patients.

03/31/2013: AEZS  NDA filing for AGHD.

03/31/2013: AUXL  Phase 2a data of XIAFLEX.

03/31/2013: DRRX NDA filing for POSIDUR

03/31/2013: IGXT  NDA filing of RIZAtriptan.

03/31/2013: INO   Phase 2 data  of DNA vaccine.

03/31/2013: INSV   Phase 3 data of Bromsite

03/31/2013: PTIE  Resubmission of Remoxy

03/31/2013: CYCC  Phase 3 data for Sapacitabine.
03/31/2013: ALIM   NDA resubmission of Illuvien for Diabetic

03/31/2013:  ANAC  Phase 2 data for AN2728 in atopic dermatitits.