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)
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Pirfenidone Capsules had estimated annual sales of USD 95 million in the US
This product will be manufactured at Lupin's Pithampur facility in India
The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat
Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).
Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).
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