Generic name:apremilast [a-PRE-mi-last] Dosage form:tablets (10 mg, 20mg, 30mg) Drug class:Antirheumatics Medically reviewed byMelisa Puckey, BPharm. Last updated on Jan 17, 2025. What is Otezla? Otezla (apremilast) tablets are used to treatplaque psoriasisto improve scaling, itching, and...
Shilpa Medicare Ltd has received US Food and Drug Administration (FDA) tentative approval for its ANDA, apremilast tablets, 10 mg, 20 mg, and 30 mg. Apremilast tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) Otezla of Celgene used in the treatme...
CNS, anti-infectives and cardiovascular drugs were the most approved in September 2021 ANDAs and these therapy areas will remain key areas of interest for generic drug manufacturers. Total first-time generic drug approvals in 2021 have exceeded the 2020 total and ar...
Is apremilast available as a generic drug? GENERIC AVAILABLE: No Do I need a prescription for apremilast? Yes What are the side effects of apremilast? The most common side effects associated with apremilast are diarrhea, nausea, and headache. It also can cause upper respiratory tract infections....
and Zydus acknowledged that its generic version of Otezla infringes eight claims in US Patent Nos. 7,427,638, 8,093,283, 8,455,536, and 10,092,541, leaving only the issues of whether Zydus's generic version of Otezla infringes US Patent No. 7,893,101 and the validity of the assert...
in a patent infringement lawsuit against Sandoz and Zydus Pharmaceuticals. The decision affirms the permanent injunction entered by the district court prohibiting Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until February 2028....