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Applicable","newsHeadline":"Aurobindo Pharma Gets USFDA Nod for Generic Antifungal Injection","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi USA, LLC","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Launches Posaconazole Injection for Prevention or Treatment of Fungal Infections","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"AUSTRIA","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Posaconazole
Launch of posaconazole delayed-release tablets, 100 mg, therapeutic generic equivalent to NOXAFIL® (posaconazole) delayed-release tablets, 100 mg approved by U.S.FDA, indicated for prophylaxis of invasive aspergillus and candida infections in patients.
Noxafil-Generic (posaconazole) is a CYP451 inhibitor drug, which is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older and candida infections.
Noxafil-Generic (posaconazole) is an azole antifungal agent. It is approved for the treatment of prophylaxis of invasive Aspergillus and Candida infections.
Posaconazole injection is the inhibition of cytochrome P-450, which is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromise.
Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane.
The primary objectives of the Phase 1 dose escalation portion of the study are to assess the safety and tolerability of DSP-5336 in relapsed or refractory AML or ALL and to determine the recommended Phase 2 dose (RP2D).
Posaconazole is approved for prophylaxis against Aspergillus and Candida infections in immunocompromised patients at high risk for these infections and oropharyngeal candidiasis.
Posaconazole has been found to be a safer and effective drug of choice for the management of the disease. The drug has received approval from the Drug Controller General of India (DCGI).
Posaconazole has been launched under the brand name PosaOne as 100 mg Delayed Release tablets and 300 mg injections, respectively. The drug has also been approved by the Drug Controller General of India (DGCI).
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