Shilpa Medicare Psoriatic arthritis drug Apremilast gets USFDA okay
Karnataka: Shilpa Medicare has recently announced that the Company has received final approval from the U.S Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg.
The medicine is indicated for the treatment of adult patients with active psoriatic arthritis. Psoriatic arthritis is a long-term inflammatory arthritis. It occurs in individuals affected by the autoimmune disease psoriasis. Swelling and pain in joints are commonly present in 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
Read also: Shilpa Medicare Bengaluru facility gets registered with Ministry of Health, UAE
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