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Strides Arcolab receives ANDA approval from US FDA for benzonatate softgel capsules

Our Bureau, BengaluruFriday, July 31, 2015, 17:20 Hrs  [IST]

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.

 
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