Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug

Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug

By: IPP Bureau

Last updated : April 11, 2023 10:26 am



Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.


Shilpa Medicare Ltd has received U.S Food and Drug Administration final approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg for the treatment of adult patients with active psoriatic arthritis. The product is executed from a contract manufacturing site.

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.

According to IQVIA MAT Q4 2022 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately US $ 3.55 Billion.

Shilpa Medicare Ltd USFDA

First Published : April 11, 2023 12:00 am