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PREVYMIS: FDA approved
prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
Pedmark: FDA approved
To reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors
Astagraf XL: FDA approved
prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients.
Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.
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Astagraf XL
(tacrolimus extended-release capsules)Orphan drugAstellas Pharma Global Development, Inc.
12.1 Mechanism of Action Tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin ...
CytoGam
(Cytomegalovirus immune globulin (human))Orphan drugstandardCSL Behring LLC
MAVYRET
(glecaprevir and pibrentasvir)Orphan drugstandardAbbVie, Inc.
Hepatitis C Virus NS3/4A Protease Inhibitor [EPC]
12.1 Mechanism of Action Mechanism of Action MAVYRET is a fixed-dose combination of glecaprevir and pibrentasvir, which are direct-acting antiviral ag...
Harvoni
(ledipasvir/sofosbuvir)Orphan drugstandardGilead Sciences, Inc.
Hepatitis C Virus NS5A Inhibitor [EPC]
12.1 Mechanism of Action HARVONI is a fixed-dose combination of ledipasvir and sofosbuvir, which are direct-acting antiviral agents against the hepati...
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