SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification
New Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm did not present adequate justification/rationale of the Vitamin C plus Vitamin D3 chewable tablet as a drug and its significant benefits among other observations.
In addition, the committee recommended the firm to submit the adequate data mentioned by the firm.
This came after the firm presented the proposal before the committee.
Vitamin C (also known as ascorbic acid and ascorbate) is a water-soluble vitamin found in citrus and other fruits, berries and vegetables. It is also a generic prescription medication and in some countries is sold as a non-prescription dietary supplement. As a therapy, it is used to prevent and treat scurvy, a disease caused by vitamin C deficiency.
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