Zydus Lifesciences gets USFDA nod for asthma drug Theophylline ER

Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Theophylline Extended-Release Tablets, 300 mg and 450 mg (USRLD: Theo-Dur Extended-Release Tablets).

Theophylline is used to treat asthma and chronic obstructive pulmonary disease (COPD). 

Asthma and chronic obstructive pulmonary disease (COPD) are both respiratory conditions that can cause breathing difficulties. Asthma is an inflammatory disorder of the airways, often triggered by allergens, irritants, or exercise. COPD, on the other hand, is primarily caused by long-term exposure to irritants like cigarette smoke, leading to chronic bronchitis and/or emphysema.

The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India. Theophylline Extended-Release Tablets, 300 mg and 450 mg had annual sales of USD 12.6 mn in the United States (IQVIA MAT March 24).

The group now has 396 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

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Medical Dialogues team had earlier reported that Zydus Lifesciences had received final approval from the USFDA to market Dexamethasone Tablets USP, 1 mg. Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer and immune system disorders.

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