4月20日FDA通知新药申请（NDA）和简化新药申请（ANDA）申办人，由位于印度班加罗尔的Semler研究私营有限责任公司（Semler Research Private Limited）开展的临床和生物分析研究，因数据可靠性问题不被接受，需要重复开展研究。Semler是一所合同研究机构，为一些制药公司开展生物等效性和生物利用度研究。
“BX”代码在橙皮书中的说明如下： BX Drug products for which the data are insufficient to determine therapeutic equivalence
The code BX is assigned to specific drug products for which the data that have been reviewed by the Agency are insufficient to determine therapeutic equivalence under the policies stated in this document. In these situations, the drug products are presumed to be therapeutically inequivalent until the Agency has determined that there is adequate information to make a full evaluation of therapeutic equivalence.
