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NOXAFIL POWDERMIX KIT (nda214770)- (300MG)

POSACONAZOLE MSD MERCK CO
300MG
No No
Expired Expired
None 2024-May-31
None No
Noxafil is an azole antifungal indicated as follows: • Noxafil injection and Noxafil delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. • Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graftversus- host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: o Noxafil injection: adults and pediatric patients 2 years of age and older o Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg o Noxafil oral suspension: adults and pediatric patients 13 years of age and older o Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 40 kg or less • Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adult and pediatric patients aged 13 years and older.
0 0 0
Total Other Developers None
Drugs with Suitability No
300MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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