Shilpa Medicare gets US FDA tentative nod for Apremilast Tablets

Shilpa Medicare has received US Food and Drug Administration (US FDA) tentative approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg dated 04 Mar 2021. The ANDA was filed as ‘First to File’ submission on NCE -1 date to seek eligibility for 180 days exclusivity.

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene used in the treatment of ‘psoriatic arthritis’ as recommended in the label approved by FDA.

According to IQVIA MAT Q2 2020 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately $2.4 billion.