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Include more govt sites for Phase III clinical trial of Ursodeoxycholic Acid Tablets: CDSCO panel to Abbott

MD BureauWritten by MD Bureau Published On 2021-02-28T11:15:58+05:30  |  Updated On 28 Feb 2021 11:16 AM IST
Include more govt sites for Phase III clinical trial of Ursodeoxycholic Acid Tablets: CDSCO panel to Abbott
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New Delhi: Suggesting to include more government sites in Phase III Clinical trial protocol, the Central Drugs Standard Control Organization (CDSCO) Committee has asked Abbott to submit a revised protocol for reviewing the additional indication of Ursodeoxycholic Acid Tablets by the committee.

Abbott presented the Phase III Clinical trial protocol before the CDSCO Committee for Ursodeoxycholic Acid Tablets IP 150mg/300mg/450mg/600mg (additional Indication).

Ursodeoxycholic Acid is a hepatoprotective medication. It works by reducing the amount of cholesterol in the blood and helps dissolve gallbladder stones that are composed mainly of cholesterol. It also improves liver enzymes, protects liver cells from injury caused due to toxic bile acids, and improves liver function.

However, the Subject Expert Committee, operative under CDSCO has suggested some revisions such as excluding patients with Hepatitis A & E infection and foetal growth retardation among others.

Also Read: Abbott launches Pedialyte Hydration Solution to support immune health

The Subject Expert Committee (SEC) in its 35th meeting held on 17.02.2021 at CDSCO HQ New Delhi reviewed the Gastroenterology and Hepatology related proposals. After detailed deliberation the committee recommended to revise the Phase III clinical trial as below:

1. Obstetric ultrasound to be performed for evaluation of foetal growth retardation at the time of enrolment.

2. Patients with Hepatitis A & E infection and foetal growth retardation should be excluded from the study.

3. Dose of the study drug should be clearly defined in the protocol along with criteria for dose titration.

4. More Government sites are to be included.

Also Read: Abbott India net profit up 1 percent to Rs 181 crore in Q2

Accordingly, the CDSCO panel directed the firm Abbott to submit the revised protocol for review by the committee.

Abbott Laboratories is a global healthcare leader having its roots in America. It has its headquarters in Abbott Park, Illinois, The United States. The company started its journey back in 1888 to formulate known drugs. In the present times, the company is involved in the manufacturing and marketing of medical devices, diagnostics, branded generic medicines, and nutritional products.

Also Read: Vikas Multicorp to enter Pharma, Healthcare business, gets nod to acquire Advik Labs

CDSCO CommitteeSubject Expert Committeesec committeeAbbottabbott newsabbott indiaUrsodeoxycholic Acid TabletsUrsodeoxycholic Acidcdsco
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    Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in.

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