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Aurobindo gets FDA approval for apremilast tablets

EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application apremilast tablets, 10mg, 20mg, and 30mg.

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application apremilast tablets, 10mg, 20mg, and 30mg. Aurobindo Pharma’s Apremilast Tablets are an AB-rated generic equivalent to the reference listed drug (RLD), OTEZLA Tablets manufactured by Amgen Inc.

Apremilast tablets are also indicated for the treatment of adult patients with active psoriatic arthritis. Indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Apremilast tablets has an estimated market size of US $3.6 Billion for the twelve months ending May 2023, as per IQVIA.

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