Unichem Labs gets US FDA nod to market muscle spasm tablets

Drug firm Unichem Laboratories said it has received approval from the US health regulator to market its Cyclobenzaprine Hydrochloride tablets used for relief of muscle spasm in the American market. The company has received abbreviated new drug application (ANDA) approval to market its Cyclobenzaprine Hydrochloride tablets USP 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (US FDA), Unichem Labs said in a filing to the BSE.

The product is a generic version of Janssen Research and Development LLC’s Flexeril tablets, it added.

The tablets will be commercialised from the company’s Goa plant, Unichem Labs said.

Cyclobenzaprine Hydrochloride tablets are indicated for the treatment as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions, it added.