Unichem Laboratories, an international, integrated and speciality pharmaceutical company, has received abbreviated new drug approval (ANDA) from US Food and Drugs Administration (FDA) for Tizanidine tablets. Tizanidine tablets USP 2mg and 4mg are therapeutically equivalent to Zanaflex tablets 2mg and 4mg marketed by Acorda Therapeutics.
The tablets belong to a group of skeletal muscle relaxants. Tizanidine tablets used to help relieve, although not cure, muscle spasms caused by medical conditions such as multiple sclerosis or injuries to the brain or spine.
The product will be commercialised from Unichem's Goa plant. Active pharmaceutical ingredients i.e. Tizanidine hydrochloride used for this ANDA is also made at its Roha plant.
Currently there are nine generic approvals, while only 3 companies are dominating the market. The current market size is US$ 70 million growing at five per cent in value terms and 10 per cent in volume.