💊Kyowa Hakko Kirin Announces the Intent to File Istradefylline (KW-6002) for Parkinson’s Disease with the US FDA

By FDA, JPN

💊Kyowa Hakko Kirin Announces the Intent to File Istradefylline (KW-6002) for Parkinson’s Disease with the US FDA

Tokyo, Japan, October 17th, 2017 — Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) today announced that it has started to prepare for filing a new drug application (NDA) Complete Response Resubmission to the U.S. Food and Drug Administration (FDA) for istradefylline (Code No. : KW-6002) based on the feedback from the FDA and the result of clinical studies separately conducted in the US and Europe, and Japan.

http://www.kyowa-kirin.com/news_releases/2017/pdf/e20171017_01.pdf

More from tokioX :

  1. Kyowa Kirin Announces FDA Approval of NOURIANZTM (istradefylline) for Use in Parkinson’s Disease
  2. 💊Pharma – News Releases
  3. 💊FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer. 〜 Hoffman-LaRoche, Inc.
  4. 💊Dainippon Sumitomo announces the launch of “Seebri ™ Neohaler®” for the treatment of chronic obstructive pulmonary disease (COPD) in the United States  20171020
  5. 💊Kyowa Hakko Kirin News、Ultragenyx and Kyowa Hakko Kirin Announce FDA Acceptance and Priority Review Designation of Burosumab’s Biologics License Application 20171010
  6. 💊Kyowa Hakko Kirin Announces Discontinuation for Developing ARQ 197 (Tivantinib)
  7. PDF]US Food and Drug Administration Grants Breakthrough Therapy Designation for Mogamulizumab for the treatment of Mycosis Fungoides and Sézary Syndrome  Kyowa Hakko Kirin News Releases