Lupin receives approval from FDA for Cyanocobalamin Nasal Spray
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
This product will be manufactured at Lupin's Pithampur facility in India
Granules now has a total of 58 ANDA approvals from US FDA
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors
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
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