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.

Strides Pharma Science Ltd周五表示，该公司的仿制药茶碱缓释片已获得美国卫生监管局的批准，该片用于治疗各种呼吸系统疾病，包括慢性哮喘。Strides Pharma在一份监管文件中表示，美国食品和药物管理局（USFDA）授予新加坡Strides Pharma Global Pte Ltd的批准是用于仿制药的茶碱缓释片300 mg和450 mg。

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.

它补充道，该产品在生物等效性和治疗上等同于参考上市药物（RLD），即先灵公司的THEO-DUR。茶碱缓释片适用于治疗与慢性哮喘和其他慢性肺病（如肺气肿和慢性支气管炎）相关的症状和可逆性气流阻塞。

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

该公司表示，茶碱缓释片（300毫克和450毫克）将在该公司位于班加罗尔KRS花园的旗舰工厂生产。该公司引用IQVIA的数据称，这些平板电脑的市场总规模约为1150万美元。