Drug Approval | June 01, 2023
Lupin receives USFDA approval from Obeticholic Acid Tablets
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder
APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop
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
Gabapentin Tablets are indicated for management of postherpetic neuralgia in adults
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).
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