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Taiho Pharmaceutical Co., Ltd.
Otsuka announces simultaneous regulatory approvals by U.S. 1xbet 다운로드®, an oral hypomethylating agent (HMA) 1xbet 다운로드
- First orally administered hypomethylating agent approved by the 1xbet 다운로드
- An option for patients with MDS 1xbet 다운로드 CMML to potentially reduce the number of office visits 1xbet 다운로드 to take their medication from the convenience 1xbet 다운로드 comfort of their homes
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) 1xbet 다운로드 have approved INQOVI®(decitabine 1xbet 다운로드 cedazuridine) tablets for intermediate 1xbet 다운로드 high-risk MDS (myelodysplastic syndromes) 1xbet 다운로드 CMML (chronic myelomonocytic leukemia), two blood malignancies.
INQOVI is the first 1xbet 다운로드 only orally administered hypomethylating agent approved in the U.S. 1xbet 다운로드 Canada for the treatment of MDS 1xbet 다운로드 CMML.
Approval in the U.S. 1xbet 다운로드 Canada was based on data from the ASCERTAIN phase three study 1xbet 다운로드 supporting phase one 1xbet 다운로드 two clinical studies. The ASCERTAIN phase three study evaluated the five-day, decitabine exposure equivalence between oral INQOVI 1xbet 다운로드 intravenous decitabine. The safety 1xbet 다운로드 efficacy of INQOVI was also assessed in the clinical studies.
The announcement is also being issued by Otsuka's California-based subsidiary Astex Pharmaceuticals, Inc.; 1xbet 다운로드 by Taiho Pharmaceutical Co., Ltd. 1xbet 다운로드 its North American subsidiaries. The three companies are all part of the Otsuka group of companies.