Drug Approval | April 11, 2023
Zydus receives final approval from the USFDA for Azithromycin Tablets
Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States
Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States
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
Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults
Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States
Pre-filled pens containing a combination of insulin glargine 100 Units/mL and lixisenatide for once-daily dosing
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
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