New Drug Applications Archive - May 2012
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May 2, 2012
May 3, 2012
- Alexza Receives Complete Response Letter for Adasuve NDA
- Napo Comments on FDA Announcing Extension of Crofelemer NDA Priority Review
May 7, 2012
May 9, 2012
- Shionogi Files a New Drug Application for Ospemifene Oral Tablets 60mg for the Treatment of Vulvar and Vaginal Atrophy
- FDA Arthritis Advisory Committee Recommends Approval of Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
- US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review
May 10, 2012
May 11, 2012
May 22, 2012
- Chelsea Therapeutics Completes End-of-Review Meeting With FDA for Northera (droxidopa) NDA
- Medivation and Astellas Announce Submission of New Drug Application for Enzalutamide for the Treatment of Castration-Resistant Prostate Cancer in Patients Previously Treated with Chemotherapy
May 23, 2012
- Bayer Submits New Drug Application for Regorafenib for the Treatment of Metastatic Colorectal Cancer
