Unichem Labs gets USFDA nod for Tizanidine tablets
New Delhi: Unichem Laboratories Ltd Thursday said it has received American health regulator's approval to market Tizanidine tablets, a drug used to relieve muscle pain, in the US market.
The company has received approval from US Food and Drug Administration (USFDA) for Tizanidine tablets in strengths of 2 mg and 4 mg, Unichem Laboratories said in a filing to BSE.
Tizanidine tablets, which are therapeutically equivalent to Acorda Therapeutics' Zanaflexm tablets, are used to help relieve muscle spasms caused by medical conditions such as multiple sclerosis or injuries to the brain and spine.
"The product will be commercialised from Unichem's Goa plant," the company said.
Currently, there are nine generic approvals for the drug, while only three companies are dominating the market, it added.
"The current market size is USD 70 million growing at 5 percent in value terms and 10 percent in volume," the company said.
Shares of Unichem Laboratories were trading at Rs 183.50 on the BSE in late afternoon trade, up 2.03 percent from their previous close.