Zydus receives USFDA nod for Phytonadione, Colchicine tablets

Zydus has received final approval from the United States Food and Drug Administration (USFDA) to market generic Phytonadione tablets USP in the strength of 5 mg, Zydus Cadila said in a statement.

Ahmedabad: Drug firm Zydus Cadila on Thursday said it has received approvals from the US health regulator for its Phytonadione tablets and Colchicine tablets.

The company has received final approval from the United States Food and Drug Administration (USFDA) to market generic Phytonadione tablets USP in the strength of 5 mg, Zydus Cadila said in a statement.

The product is used to treat and prevent low levels of blood clotting factors that the body naturally produces when caused by vitamin K deficiency or interference with vitamin K activity, it added.

The group also received the final approval for generic Colchicine tablets USP, 0.6 mg, Zydus Cadila said

The product is used to prevent or treat attacks of gout, it added.

Acute gout attacks are characterized by a rapid onset of pain in the affected joint followed by warmth, swelling, reddish discolouration, and marked tenderness. The small joint at the base of the big toe is the most common site for an attack.

The group now has 250 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.

Headquartered at Ahmedabad, the company discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 23,000 people worldwide and is working on creating healthier communities globally. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.

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