New Delhi: Drug firm Jubilant Life Sciences on Saturday said it has received final approval from the US health regulator for its Tizanidine Hydrochloride capsules used for management of spasticity.
Jubilant Pharma Ltd has received Abbreviated New Drug Application (ANDA) final approval for Tizanidine Hydrochloride capsules in the strengths of 2 mg, 4 mg, and 6 mg, Jubilant Life Sciences said in a BSE filing.
The product is generic version of Acorda’s Zanaflex capsules, it added.
The capsules are used for the management of spasticity, Jubilant Life Sciences said.
Spasticity is a condition in which people can suffer severe, painful muscle spasms and/or rigidity during the day and night.
“This is the fifth approval that we have received from the USFDA during the current financial year”, it added.
As on June 30, 2017, the company had a total of 84 ANDAs for oral solids filed in the US, of which 53 have been approved, Jubilant Life Sciences said.