Alembic Pharma announced that it has received tentative approval from the US Food and 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 (RLD) product Corlanor tablets, 5 mg and 7.5 mg, of Amgen, Alembic Pharma notified in a statement. 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 per cent, 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. Click for more articles on USFDA Ivabradine tablets are indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric 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, the statement added. USFDA gives nod to Lupin for Desvenlafaxine ER tablets USFDA authorises first C-19 diagnostic test using breath samples USFDA gives approval to Aleor for Lidocaine & Prilocaine cream USFDA gives nod to Indoco Remedies for Lacosamide injection USFDA gives tentative approval to Alembic for generic Pradaxa capsules USFDA approves Cell Therapy for earlier lymphoma AIDCOC has represented to MPSC to revise the education qualification advertised for the post of Assistant Commissioner IPGA in association with DCO INDIA DRUGS CONTROL FORUM organized an International Webinar on DESIGNER DRUGS NPPA expert panel decides not to fix ceiling price of Clotrimazole… NPPA fixes Retail Price of 15 formulations: April 2022 USFDA gives nod to Lupin for Desvenlafaxine ER tablets Drug recall: Insulin Glargine recalled due to this reason DCGI: Fourfold increase in Investigational New Drugs Applications in India 4 Medical Devices Parks to come up in a total of 1,326 acres CDSCO Committee gives approval to Sun Pharma for Ranibizumab Latest Notifications regarding Pharmaceuticals
https://thehealthmaster.com/2022/04/21/usfda-gives-tentative-nod-to-alembic-pharma-for-ivabradine-tablets/