NEW DELHI: Drug firm Strides Arcolab has received approval from the US health regulator for its Benzonatate softgel capsules used for treating cough caused by cold, and other breathing problems such as pneumonia and asthma.
The product will be launched immediately in the US market, Strides Arcolab said in a filing to BSE.
The company has received approval from the United States Food and Drug Administration (USFDA) for Benzonatate softgel capsules in the strengths of 100mg and 200 mg, it added.
“According to IMS data, the US market for Benzonatate is approximately USD 41 million,” Strides Arcolab said.
The product will be manufactured at the company’s oral dosage facility at Bengaluru and marketed by the company in the US, it added.
Strides Arcolab is a bang lore based pharmaceutical company manufacturing pharmaceutical products, OTC drugs and nutraceuticals