Drug Approval | October 07, 2023
Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Clindamycin Phosphate Gel is used to treat acne
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States
The products will be manufactured at the company's facility in Bengaluru
The products will be manufactured at the company's facility in Bengaluru
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