SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification

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.

Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.

At the recent SEC meeting for Antimicrobial and Antiviral held on 14th May 2025, the expert panel reviewed the proposal presented by the firm.

After detailed deliberation, the committee opined the following:

1. The firm did not present adequate justification/rationale for the proposed FDC as a drug and its significant benefits

2. Published scientific literature in peer reviewed journal in support of essentiality and desirability of proposed FDC is not presented.

3. Firm was not able to present justification on selection of strength of Vitamin D3 in the proposed FDC

4. The proposed FDC is not approved internationally

5. The firm did not present Published scientific literature of FDC for proposed indication.

Accordingly, the expert panel recommended that the firm should submit above data/documents for further review by the committee.

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