Akums Pharma gets CDSCO panel nod To Manufacture, Market FDC of doxylamine and pyridoxine

This came after Akum Drugs and Pharmaceutical presented a bioequivalence (BE) study report of the FDC Pyridoxine HCl IP (ER) 20mg plus Doxylamine succinate (ER) 20mg tablets.

The committee noted that the said FDC is already approved in the US, Canada, etc.

The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women whose symptoms have not improved after changing their diet or using other non-medicine treatments.

Pyridoxine hydrochloride is a water-soluble vitamin. Pyridoxine (vitamin B6) is used to prevent or treat low levels of vitamin B6 in people who do not get enough of the vitamin from their diets. Vitamin B6 plays an important role in the body. It is needed to maintain the health of nerves, skin, and red blood cells.

Doxylamine is an antihistamine, used to relieve symptoms of allergy, hay fever, and the common cold. As a member of the first-generation class of antihistamines, doxylamine exerts its effects by competitively antagonizing the binding of free histamine at the H1-receptor binding sites. It antagonizes the effects of histamine in the uterus, GI tract, large blood vessels, and bronchial muscles.

Doxylamine plus Vitamin B6 (Pyridoxine) is a combination of two medicines: Doxylamine and vitamin B6 (pyridoxine), which treat nausea and vomiting associated with pregnancy. Doxylamine is an antihistamine that works by blocking the action of a chemical messenger (histamine), thereby controlling nausea, vomiting, and dizziness. Pyridoxine (vitamin B6) is a form of vitamin B which possesses anti-nausea properties.

At the recent SEC meeting for the Reproductive and Urology held on 19th October 2023, the expert panel reviewed the BE study report of the FDC Pyridoxine HCl IP (ER) 20mg plus Doxylamine succinate (ER) 20mg tablets presented by the drug major Akum Drugs and Pharmaceutical.

The committee noted that the said FDC is already approved in the US, Canada, etc.

After detailed deliberation, the committee considered the Phase III clinical trial (CT) waiver and recommended the grant of permission for manufacturing and marketing of the FDC with the condition of conducting the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months of approval of the FDC.

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