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New Drug Applications Archive - January 2013

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January 3, 2013

Merck Announces FDA Acknowledgement of Resubmission of New Drug Application for Ezetimibe/Atorvastatin Tablets

January 7, 2013

Merck Announces FDA Acceptance of Resubmission of New Drug Application for Sugammadex Sodium Injection

January 8, 2013

GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe

January 11, 2013

FDA Advisory Committee Recommends Approval of Canagliflozin for Treatment of Adults with Type 2 Diabetes

January 14, 2013

GSK Announces Submission of Albiglutide BLA to the US FDA for the Treatment of Type 2 Diabetes

January 15, 2013

U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC

January 16, 2013

QRxPharma and FDA Establish Path Forward for Resubmission Of Moxduo New Drug Application

January 25, 2013

FDA Issues Complete Response Letter for Rytary (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application

January 28, 2013

Genzyme's Lemtrada (alemtuzumab) Application for MS Accepted for Review by the FDA

January 30, 2013

FDA Advisory Committee Recommends Approval for Boehringer Ingelheim's Olodaterol for Maintenance Treatment of COPD

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