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| Alembic Pharma receives tentative approval for Ivabradine tablets from USFDA | | | agencies
MUMBAI, Apr 20: Pharma major Alembic Pharma on Wednesday said that it has received tentative approval from the US Food & Drug Administration (USFDA) 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 Rs 35 per cent, who are in sinus rhythm with resting heart rate Rs 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 pediatric 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. |
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