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

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, from the United States Food and 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 ~ $ 11.5 million, with the 300 mg dosage contributing ~ $ 10.8 million 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 Bengaluru, India.