New Drug Application News and Research

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Sucampo's supplemental new drug application for AMITIZA gets FDA approval

Sucampo's supplemental new drug application for AMITIZA gets FDA approval

24 Apr 2013
Gilead Sciences to present results from four Phase 3 clinical trials at International Liver Congress 2013

Gilead Sciences to present results from four Phase 3 clinical trials at International Liver Congress 2013

23 Apr 2013
Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

Enrollment for Pharmacyclics' Phase III study using ibrutinib in CLL patients completed

23 Apr 2013
Phase 2 study of VX-661 and ivacaftor shows significant improvements in lung function among CF patients

Phase 2 study of VX-661 and ivacaftor shows significant improvements in lung function among CF patients

22 Apr 2013
Romark Laboratories starts NT-300 Phase 3 trial for treatment of acute uncomplicated influenza

Romark Laboratories starts NT-300 Phase 3 trial for treatment of acute uncomplicated influenza

19 Apr 2013
FDA's PADAC supports approval of BREO ELLIPTA as once-daily inhaled treatment for COPD

FDA's PADAC supports approval of BREO ELLIPTA as once-daily inhaled treatment for COPD

18 Apr 2013
Mast Therapeutics' data show that MST-188 reduces aggregation of both older and younger RBC

Mast Therapeutics' data show that MST-188 reduces aggregation of both older and younger RBC

18 Apr 2013
FDA issues Complete Response Letter to Allergan's NDA for LEVADEX

FDA issues Complete Response Letter to Allergan's NDA for LEVADEX

17 Apr 2013
FDA approves Taro's NDA for Topicort Topical Spray

FDA approves Taro's NDA for Topicort Topical Spray

15 Apr 2013
FDA accepts Otsuka Pharmaceutical's tolvaptan NDA for priority review

FDA accepts Otsuka Pharmaceutical's tolvaptan NDA for priority review

15 Apr 2013
FDA accepts Merck's NDA for NOXAFIL tablets

FDA accepts Merck's NDA for NOXAFIL tablets

11 Apr 2013
FDA approves PROLENSA for treatment of inflammation, pain after cataract surgery

FDA approves PROLENSA for treatment of inflammation, pain after cataract surgery

9 Apr 2013
Gilead Sciences submits sofosbuvir NDA to FDA for treatment of chronic HCV infection

Gilead Sciences submits sofosbuvir NDA to FDA for treatment of chronic HCV infection

9 Apr 2013
FDA grants priority review for Bayer HealthCare's riociguat for treatment of CTEPH

FDA grants priority review for Bayer HealthCare's riociguat for treatment of CTEPH

8 Apr 2013
Noven Pharmaceuticals files ANDA with FDA for approval of generic version of Exelon

Noven Pharmaceuticals files ANDA with FDA for approval of generic version of Exelon

4 Apr 2013
Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

Tris Pharma gets FDA NDA approval for Karbinal ER Extended-release Oral Suspension

4 Apr 2013
FDA approves Mylan's ANDA for generic version of Zovirax Ointment

FDA approves Mylan's ANDA for generic version of Zovirax Ointment

4 Apr 2013
BioCryst Pharmaceuticals receives preliminary comment letter from FDA on peramivir

BioCryst Pharmaceuticals receives preliminary comment letter from FDA on peramivir

1 Apr 2013
Medivir seeks FDA approval for simeprevir

Medivir seeks FDA approval for simeprevir

30 Mar 2013
POZEN announces submission of NDA for marketing approval of PA32540/PA8140

POZEN announces submission of NDA for marketing approval of PA32540/PA8140

27 Mar 2013

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