Unichem Labs gets US FDA nod for muscle relaxant Tizanidine

Pharmaceutical company Unichem Laboratories  has received abbreviated new drug approval (ANDA) from US Food and Drugs Administration for a copy of Tizanidine tablets, used as a muscle relaxant. The news sent its shares up over 2 percent in afternoon trade.

The drug is used to help relieve, although not cure, muscle spasms caused by medical conditions such as multiple sclerosis or injuries to the brain or spine, it said.

Unichem's Tizanidine tablets in 2mg and 4mg strength are therapeutically equivalent to Zanaflex tablets marketed by Acorda Therapeutics.

The current US market size for the drug is USD 70 million, growing at 5 percent in value terms and 10 percent in volume, the company said.

The product will be commercialised from Unichem's Goa plant. The ANDA is also made at its Roha plant.

At 13:00 hrs, Unichem shares were up 2.5 percent at Rs 184.55 on NSE.