Strides receive USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg

Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), THEO-DUR®, of Schering Corp. Theophylline extended-release tablets are indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. 

Theophylline Extended-Release Tablets, 300 mg and 450 mg have a combined market size of ~USD  11.5 mn, with the 300 mg dosage contributing ~USD 10.8 mn as per IQVIA. The Theophylline Extended-Release Tablets, 300 mg and 450 mg will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India.

Theophylline Extended-Release Tablets (300 mg and 450 mg) are used to manage respiratory conditions like chronic asthma, chronic obstructive pulmonary disease (COPD), and bronchospasm. The medication works as a bronchodilator, relaxing the muscles around the bronchial tubes to ease breathing. It is particularly helpful in preventing and treating symptoms such as wheezing, shortness of breath, and chest tightness. The extended-release formulation allows for prolonged drug release, reducing the frequency of dosing and providing consistent relief from symptoms over time.