Strides gets US FDA nod for Theophylline tablets

6 Sep 2024 , 12:18 PM

Strides Pharma Science Ltd announced on Friday that its unit has got approval from the US health agency for its generic version of Theophylline extended-release tablets, which are indicated for the treatment of a variety of respiratory disorders, including persistent asthma.

The US Food and Drug Administration (USFDA) has approved Strides Pharma Global Pte Ltd, Singapore, for a generic version of Theophylline Extended-Release Tablets 300 mg and 450 mg, according to a regulatory filing.

The medication is bioequivalent and therapeutically equivalent to Schering Corp’s Reference Listed Drug (RLD), THEO-DUR, the company said.

Theophylline extended-release pills are used to treat the symptoms and reversible airflow restriction that come with chronic asthma and other chronic lung disorders like emphysema and chronic bronchitis.

Theophylline extended-release pills (300 mg and 450 mg) will be manufactured at the company’s flagship facility in Bengaluru’s KRS Gardens, according to the announcement.

According to the business, the aggregate market size for these tablets is around USD 11.5 million, based on IQVIA statistics.

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