Zydus Cadila gets US FDA nod for Tizanidine tablets

The approval by the US Food and Drug Adminstration (US FDA) is for multiple strengths of 2 mg and 4 mg

Cadila Healthcare said its group firm Zydus Cadila has received final approval from the US health regulator for its generic version of Tizanidine tablets used for treatment of muscle spasms. The approval by the US Food and Drug Adminstration (US FDA) is for multiple strengths of 2 mg and 4 mg, the company said in a BSE filing. The tablets will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, the company added. Tizanidine tablets are used to treat muscle spasms caused by certain conditions such as multiple sclerosis, spinal cord injury, it said. The group has more than 180 approvals with over 320 abbreviated new drug approvals (ANDAs) filed since 2003-04, the company said.