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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Morepen Laboratories approves hiving off of medical devices business
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Biocon Biologics remains committed to global standards of quality and compliance
If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy
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