Alembic得到FDA暂时批准 治疗某些白血病病人的Bosutinib Alembic gets FDA tentative approval for generic Bosutinib to treat certain leukemia patients.

Alembic制药公司已经得到林业发展局暂时批准的400毫克的Bosutinib药片,这些药片用于治疗患有费城染色体阳性慢性近血素白血病的成年病人,包括新诊断或抗前科疗法的病人。 Alembic Pharmaceuticals has received tentative FDA approval for its 400 mg generic Bosutinib tablets, used to treat adult patients with Philadelphia chromosome-positive chronic myelogenous leukemia, including those newly diagnosed or resistant to prior therapies. 通过补充ANDA的批准,确认治疗等同于品牌药物Bosulif。 The approval, via a supplemental ANDA, confirms therapeutic equivalence to the brand-name drug Bosulif. 此前曾核准使用100毫克和500毫克的剂量。 This follows earlier approvals for 100 mg and 500 mg strengths. 市场进入正在等待专利或排他性问题的解决。 Market entry is pending resolution of patent or exclusivity issues.