Akums Gets CDSCO panel Nod To Manufacture, Market Bisoprolol Fumarate
New Delhi: Considering the request of the drug major Akum Pharmaceuticals for a bioequivalence study (BE) and clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to manufacture and market the competitive, cardioselective β1-adrenergic antagonist, Bisoprolol Fumarate tablets 3.75mg/7.5mg.
This came after Akum Pharmaceuticals presented the proposal for manufacturing and marketing Bisoprolol Fumarate tablets 3.75mg/7.5mg along with approval status of the product in key countries, facts for BE, and clinical trial study waiver with justification, supporting data/ literature, etc. before the committee.
Bisoprolol is a beta-1 adrenergic blocking agent used to prevent myocardial infarction and heart failure and to treat mild to moderate hypertension. Bisoprolol fumarate is indicated for the treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, diuretics, and optionally cardiac glycosides.
Bisoprolol is a competitive, cardioselective β1-adrenergic antagonist. When β1-receptors (located mainly in the heart) are activated by adrenergic neurotransmitters such as epinephrine, both the blood pressure and heart rate increase, leading to greater cardiovascular work, increasing the demand for oxygen. Bisoprolol reduces cardiac workload by decreasing contractility and the need for oxygen through competitive inhibition of β1-adrenergic receptors.
Bisoprolol is also thought to reduce the output of renin in the kidneys, which normally increases blood pressure.
At the recent SEC meeting for Cardiovascular and Renal held on 19th July 2023, the expert panel reviewed the proposal presented by the drug major Akum Pharmaceuticals to market and manufacture the cardiovascular drug Bisoprolol Fumarate tablets 3.75mg/7.5mg along with the approval status of the product in key countries, facts for BE and clinical trial study waiver with justification, supporting data/ literature, etc.
After detailed deliberation, the committee considered the request of the firm for a Bioequivalence study and clinical trial waiver and recommended the grant of permission for manufacturing and marketing of the applied product Bisoprolol Fumarate tablets 3.75mg/7.5mg for already approved indication.
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