Alembic Pharma gets US FDA tentative nod for ivabradine tablets
Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (FDA) 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 hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction = 35%, who are in sinus rhythm with resting heart rate = 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use.
Ivabradine tablets are indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in paediatric patients aged 6 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 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 US FDA.
Let’s apply Data-Driven Pricing to Your APIs
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions!
Learn More!