New Drug Applications Archive
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News Archive for December 2011
December 1, 2011
- Regulatory Update: Glaxosmithkline Submits Additional Information for Candidate Meningococcal and Hib Combination Vaccine
- NPS Pharmaceuticals Completes Submission of New Drug Application for Gattex (teduglutide) in Adult Short Bowel Syndrome (SBS)
December 6, 2011
December 7, 2011
December 8, 2011
December 13, 2011
December 14, 2011
December 15, 2011
- FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
- FDA Extends Taliglucerase Alfa PDUFA Date to May 1, 2012
December 20, 2011
- Pfizer Announces FDA Acceptance for Review of New Drug Application for Tofacitinib for Adult Patients with Moderately to Severely Active Rheumatoid Arthritis
- Santarus Submits New Drug Application to FDA for Uceris (budesonide) Tablets
