Strides Arcolab receives ANDA approval from US FDA for benzonatate softgel capsules
Strides Arcolab has received approval from the United States Food & Drug Administration (FDA) for benzonatate capsules USP, 100 mg and 200 mg.
According to IMS data, the US market for benzonatate is approximately US$ 41 million.
The product will be manufactured at the company’s oral dosage facility in Bengaluru and marketed by Strides in the US Market. The product will be launched immediately.
Benzonatate is used to treat coughs caused by the common cold and other breathing problems like for instance pneumonia, bronchitis, emphysema and asthma. It works by reducing the reflex in the lungs
The company has 8 manufacturing facilities presence in more than 75 countries in developed and emerging markets.