Zydus Cadila gets tentative USFDA nod for arthritis drug Apremilast

The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market generic Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Zydus Cadila said in a filing to BSE.

New Delhi: Drug firm Zydus Cadila on Saturday said it has received tentative approval from the US health regulator to market generic Apremilast tablets.

The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 10 mg, 20 mg, and 30 mg, Zydus Cadila said in a filing to BSE.

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This medication is used to treat psoriatic arthritis and moderate to severe plaque psoriasis. It is also used to treat mouth sores in people who have Behcet's disease, it added.

The tablets will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad, Zydus Cadila said.

The group now has 276 approvals and has so far filed over 360 ANDAs since the commencement of its filing process, it added.

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