Zydus Lifesciences Gets USFDA Nod for Generic Heart Failure Drug

New Delhi, Dec 1 (PTI) Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator for its generic version of Ivabradine tablets indicated for the treatment of heart failure.

The approval by the US Food and Drug Administration (USFDA) is for Ivabradine tablets of strengths 5 mg and 7.5 mg, the company said in a regulatory filing.

The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India, it added.

Ivabradine is indicated to reduce the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with certain conditions, the company said.

It is also used in children aged six months and older for the treatment of stable
symptomatic heart failure due to cardiomyopathy, it added.

Zydus said it was one of the first abbreviated new drug application (ANDA) applicants to submit a substantially complete ANDA with a paragraph IV certification for Ivabradine Tablets, 5 mg and 7.5 mg, and therefore, may be eligible for 180 days of shared generic exclusivity for the same.

Ivabradine tablets, 5 mg and 7.5 mg recorded annual sales of USD 136.5 million in the US, the company said, citing IQVIA MAT October 2023 data.