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.
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