Strides Pharma Science gets USFDA nod for Theophylline Extended-Release tablets

Strides Pharma Science Limited has recently informed exchanges that its step-down entirely 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 and Drug Administration (USFDA).

In the exchange filing the company also shared, “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.”

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In the meantime, as of 10:15 am, Strides Pharma Science shares were trading 1.96% higher at Rs 1,371.15 on the NSE.