India Pharma Outlook Team | Wednesday, 20 April 2022
Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) for Ivabradine tablets, 5 mg and 7.5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). Ivabradine tablets are indicated to reduce the risk of
hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with a left ventricular ejection fraction of 35 per cent, who are in sinus rhythm with a resting heart rate of 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.
The tablets are also indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in paediatric patients aged six months and older who are in sinus rhythm with an elevated heart rate.
It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses. Ivabradine Tablets, 5 mg and 7.5 mg, have an estimated market size of US $102 million for the twelve months ending December 2021, according to IQVIA. Alembic has received a cumulative total of 164 ANDA approvals (140 final approvals and 24 tentative approvals) from the USFDA.
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