Zydus Lifesciences receives USFDA approval for Ivabradine tablets

On Friday, shares of Zydus Lifesciences were up/down by 0.34 per cent, ending the day's trade at Rs 640 apiece on the BSE

Zydus Lifesciences on Friday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Ivabradine Tablets, 5 mg and 7.5 mg  (USRLD: Corlanor® Tablets, 5 mg and 7.5 mg).

Ivabradine is used to reduce the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure featuring reduced left ventricle ejection fraction. It is also used in children aged 6 months and older for the treatment of stable symptomatic heart failure due to cardiomyopathy (weakening of heart muscles). 

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India, Zydus said in a press statement.

 

“Zydus is one of the first applicants to submit a substantially complete Abbreviated New Drug Application (ANDA) with a paragraph IV certification for Ivabradine Tablets, 5 mg and 7.5 m, and therefore may be eligible for 180 days of shared generic exclusivity,” the company said.

Eligibility of shared generic exclusivity can provide manufacturing and marketing exclusivity for a generic drug to multiple applicants, who have submitted an ANDA on the same date.  

Ivabradine Tablets, 5 mg and 7.5 mg, had annual sales of $136.5 million in the United States, according to IQVIA’s Moving Annual Total (MAT) data.

The group now has 382 approvals and has so far filed over 448 ANDAs since the commencement of the ANDA filing process in FY 2003-04. 

On Friday, shares of Zydus Lifesciences were up by 0.34 per cent, ending the day's trade at Rs 640 apiece on the BSE.