New Drug Applications Archive - June 2016
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June 6, 2016
- Shionogi Announces Acceptance of NDA for Naldemedine for the Treatment of Opioid-Induced Constipation
- Sarepta Therapeutics Announces FDA Request For Dystrophin Data Prior To Making A Decision on Eteplirsen NDA
- Adamis Pharmaceuticals Receives Complete Response Letter From FDA For Its Epinephrine Pre-Filled Syringe NDA
June 7, 2016
June 8, 2016
June 9, 2016
June 13, 2016
- FDA Issues Complete Response Letter for Apadaz New Drug Application
- Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108
- Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab
June 14, 2016
June 17, 2016
June 21, 2016
June 22, 2016
June 27, 2016
- Medimetriks Pharmaceuticals, Inc. Submits NDA to FDA for Ozenoxacin Cream for Impetigo
- Advanced Accelerator Applications Announces FDA Priority Review for Lutathera
