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Zydus Cadila gets USFDA nod to market 2 drugs

PTI New Delhi | Updated on April 25, 2018 Published on April 25, 2018

Drug firm Zydus Cadila today said it has received final approval from the US health regulator to market two drugs used for the treatment of various conditions, including blood disorders, certain types of cancers, kidney and lung ailments.

The United States Food and Drug Administration (USFDA) has given its nod to market Zydus Cadila’s Methylprednisolone tablets and Cinacalcet hydrochloride tablets in the American market.

The approval has been granted for Methylprednisolone tablets USP in the strengths of 4 mg, 8 mg, 16 mg and 32 mg and Cinacalcet hydrochloride tablets in the strengths of 30 mg, 60 mg and 90 mg, Zydus Cadila said in a statement.

Methylprednisolone tablets will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad, it added.

The tablets are used to treat various conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin, kidney, intestinal, lung diseases and immune system disorders, Zydus Cadila said.

The group has also received the final approval to market Cinacalcet hydrochloride tablets in the strengths of 30 mg, 60 mg and 90 mg.

The product will be manufactured at the group’s formulations manufacturing facility at SEZ Ahmedabad, Zydus Cadila said.

The tablets are” indicated for the treatment of high blood calcium in patients with cancer of parathyroid glands and for the treatment of high blood parathyroid hormone levels seen in patients with chronic kidney disease on dialysis,” it added.

Shares of Cadila Healthcare, the listed entity of the group, today closed at ₹ 402.20 on the BSE, down 0.51 per cent from their previous close.

Published on April 25, 2018
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