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  • Abbott Healthcare Gets...

Abbott Healthcare Gets CDSCO Panel Nod To Manufacture Market Ursodeoxycholic acid for Obstetric Cholestasis

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-12-01T17:15:26+05:30  |  Updated On 1 Dec 2024 5:15 PM IST
CDSCO Panel Clears Abbotts Phase IV Trial for Empagliflozin + Metformin FDC, Seeks More Sites
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New Delhi: Abbott Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Ursodeoxycholic acid tablets (IP 150 mg/300 mg/450 mg/600 mg tablet) for the treatment of obstetric cholestasis (intrahepatic cholestasis of pregnancy) with a condition that the firm should conduct a postmarketing surveillance (PMS) study.

In addition, the committee asked the firm to submit the PMS study protocol to CDSCO within 3 months from the date of approval of the drug for further evaluation.

This came after Abbott Healthcare presented the clinical study report before the committee.

Obstetric cholestasis (OC), also known as intrahepatic cholestasis of pregnancy (ICP), is a liver condition that can occur during pregnancy. The most common symptom is severe itching that can be all over the body, but is often worse on the hands and feet. Itching can be constant or recurrent, and is often worse at night. Other symptoms include dark urine, pale stools, tiredness, reduced appetite, and feeling sick.

Ursodeoxycholic acid (UDCA) is a secondary bile acid with cytoprotectant, immunomodulating, and choleretic effects. It reduces the cholesterol fraction of biliary lipids. UDCA inhibits the absorption of cholesterol in the intestine and the secretion of cholesterol into bile, decreasing biliary cholesterol saturation.

Ursodeoxycholic acid improves biliary flow, enhances the protective bicarbonate environment on the surface of cholangiocytes, and protects the liver from bile acid-induced apoptosis. This therapy has anti-inflammatory actions, and can reduce the elevation of serum bile acid concentration in the fetus, probably by upregulating placental bile acid export. As ursodeoxycholic acid is a bile acid, its use results in alteration of the bile acid pool so that it constitutes 60–70% of total bile acids in treated women and replaces more harmful (hydrophobic) bile acids.

At the recent SEC meeting for gastroenterology and hematology held on November 14, 2024, the expert panel reviewed the clinical study report of the drug ursodeoxycholic acid.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market ursodeoxycholic acid IP 300 mg/450 mg tablets as the firm has conducted the clinical study with 300 mg/450 mg tablets for the treatment of obstetric cholestasis (Intrahepatic Cholestasis of pregnancy) with the condition that the firm should conduct a postmarketing surveillance (PMS) study.

Accordingly, the expert panel stated that the firm should submit a PMS study protocol to CDSCO within 3 months from the date of approval of the drug for further review by the SEC Committee.

Also Read: SEC Committee Recommends Metformin SR for Gestational Diabetes; Final Approval Pending

abbott healthcarecdscoUrsodeoxycholic AcidObstetrics cholestasis
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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