Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Sprycel, NDAs 21- 986 and 22-072 is 1,183 days for extending a patent which claims the human drug product. Sprycel is indicated for treating adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib. It is also indicated for treating adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy. To view this notice, click here.