Strides’ new drug gets FDA nod

The US regulatory body has approved the company’s Calcitriol softgel capsules

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The product will be manufactured at its oral dosage facility at Bengaluru

Strides Acrolab has announced that the United States Food and Drug Administration (US FDA) has approved its Calcitriol softgel capsules used for the treatment of patients with kidney disease who have vitamin D deficiency.

The company has received the approval for capsules in the strengths of 0.25mcg and 0.5mcg.

According to the company, the product will be manufactured at its oral dosage facility at Bengaluru and marketed in the US market.

The US market for generic Calcitriol softgel capsules is approximately $50 million, according to IMS data.

 

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