A CRL is issued when the FDA decides not to approve new or generic drug application for marketing in its present form
The product is a generic version of Takeda Pharmaceutical Company's Rozerem tablets in the same strength
Under the agreement, Dr Reddy's sold its US and select territory rights for Zembrace Symtouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg
Allegra-D 12 HR is a trademark of Aventisub II Inc
Gleevec and its generic equivalents saw sales of approximately $868 mn in the US for the last twelve months ending in July 2018