Drug Approval | April 11, 2023
Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop
Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms
Acetazolamide is used to treat glaucoma
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
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