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Unichem Laboratories Ltd today said that 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 the US Food and Drug Administration (USFDA) for Tizanidine tablets in strengths of 2 mg and 4 mg, Unichem Laboratories said in a filing to the 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 $70 million growing at five per cent in value terms and 10 per cent 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 per cent from their previous close.
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