Strides gets USFDA nod for Theophylline extended-release tablets

Strides Pharma Science Ltd on Friday said its arm has received approval from the US health regulator for its generic version of Theophylline extended-release tablets indicated for management of various respiratory conditions, including chronic asthma. The approval granted by the US Food & Drug Administration (USFDA) to Strides Pharma Global Pte Ltd, Singapore, is for generic version of Theophylline Extended-Release Tablets 300 mg and 450 mg, Strides Pharma said in a regulatory filing.


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


Theophylline extended-release tablets are indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, such as emphysema and chronic bronchitis.


The Theophylline extended-release tablets -- 300 mg and 450 mg -- will be manufactured at the company's flagship facility in KRS Gardens in Bengaluru, the company said.

These tablets have a combined market size of about USD 11.5 million, the company said, citing IQVIA data.