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Submit Scientific Evidence: CDSCO Panel Tells Bayer on Vericiguat Warning Statement Amendment Proposal
New Delhi: In response to the proposal presented by Bayer Pharmaceuticals for amendment in the warning statement for Vericiguat 2.5 mg, 5 mg, and 10 mg film-coated tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended submitting the scientific evidence/data to CDSCO for further deliberation.
This came after Bayer Pharmaceuticals presented the proposal for amendment in the warning statement of permission granted to import and market Vericiguat 2.5 mg, 5 mg, and 10 mg film-coated tablets before the committee.
Vericiguat is in a class of medications called soluble guanylate cyclase (sGC) stimulators. It works by relaxing the blood vessels in the lungs to allow blood to flow easily.
The soluble guanylate cyclase stimulators act by nitric oxide, which is an independent enhancement of soluble guanylate cyclase activity along with increased sensitivity of sGC to endogenous nitric oxide. Absorption: The bioavailability of vericiguat is 93% when taken with food.
At the recent SEC meeting for Cardiovascular held on July 9, 2024, the expert panel reviewed the proposal for amendment in the warning statement of permission granted to import and market Vericiguat 2.5 mg, 5 mg, and 10 mg film-coated tablets before the committee
After detailed deliberation, the committee recommended that the firm should submit the scientific evidence/data to CDSCO for further deliberation before the committee.
Also Read: Dr Reddy's Laboratories Gets CDSCO Panel Nod To Study Rebamipide, Sodium Alginate Suspension
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-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