Strides Pharma Secures FDA Nod for Asthma Drug

Strides Pharma Science Ltd's arm has won US FDA approval for its generic version of Theophylline extended-release tablets, used primarily for chronic asthma management. These tablets will be manufactured at the firm’s Bengaluru facility and have a market size of about USD 11.5 million.

Strides Pharma Science Ltd announced on Friday that its subsidiary has received approval from the US health regulator for its generic version of Theophylline extended-release tablets, which are prescribed for managing various respiratory conditions, including chronic asthma.

The US Food & Drug Administration (USFDA) granted approval to Strides Pharma Global Pte Ltd, Singapore, for the generic version of Theophylline Extended-Release Tablets in 300 mg and 450 mg strengths. This product is bioequivalent and therapeutically equivalent to Schering Corp's THEO-DUR, the company revealed in a regulatory filing.

The tablets, intended for treatment of chronic asthma symptoms and other chronic lung diseases such as emphysema and chronic bronchitis, will be manufactured at Strides Pharma's flagship facility in KRS Gardens, Bengaluru. According to IQVIA data, these tablets have a combined market size of approximately USD 11.5 million.

(With inputs from agencies.)