Shares of Strides Pharma Science Ltd. surged nearly by 4% to a day’s high of Rs 1,395 on 6th September, after the company’s subsidiary received US Food and Drug Administration (USFDA) approval for its chronic asthma treatment drug.

Strides Pharma Global Pte. Ltd., a subsidiary of the company, has obtained approval from the US FDA for its generic version of Theophylline Extended Release Tablets in 300 mg and 450 mg strengths.

The company is the first approved applicant for this drug and is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity.

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), THEO-DUR, made by Schering Corp.

Theophylline extended-release tablets are used to treat symptoms and reversible airflow obstruction in chronic asthma and other lung diseases, including chronic bronchitis, COPD, emphysema, and bronchospasm.

The medication acts as a bronchodilator, relaxing the muscles around the bronchial tubes to improve breathing and alleviate symptoms such as wheezing, shortness of breath, and chest tightness. The extended-release formulation also reduces the frequency of dosing and provides longer-lasting relief.

Theophylline Extended-Release Tablets have a combined market size of $11.5 million, with the 300 mg dosage contributing $10.8 million, according to IQVIA.

Strides Pharma will manufacture the tablets at 300 mg and 450 mg dosages at its facility in KRS Gardens, Bengaluru.

At 1:09 PM, the shares of Strides Pharma were trading 1.17% higher at Rs 1,360.60 on NSE.

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