NOXAFIL Drug Patent Profile

Which patents cover Noxafil, and when can generic versions of Noxafil launch?

Noxafil is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co. and is included in four NDAs. There are six patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-eight patent family members in twenty-four countries.

The generic ingredient in NOXAFIL is posaconazole. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the posaconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Noxafil

A generic version of NOXAFIL was approved as posaconazole by SINOTHERAPEUTICS INC on August 21^st, 2019.

Summary for NOXAFIL

International Patents:	78
US Patents:	6
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	24
Patent Applications:	1,644
Drug Prices:	Drug price information for NOXAFIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOXAFIL
What excipients (inactive ingredients) are in NOXAFIL?	NOXAFIL excipients list
DailyMed Link:	NOXAFIL at DailyMed

See drug prices for NOXAFIL

Recent Clinical Trials for NOXAFIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Milton S. Hershey Medical Center	Early Phase 1
M.D. Anderson Cancer Center	Phase 1/Phase 2
Cidara Therapeutics Inc.	Phase 3

See all NOXAFIL clinical trials

Pharmacology for NOXAFIL

Drug Class

Azole Antifungal

Paragraph IV (Patent) Challenges for NOXAFIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NOXAFIL	Injection	posaconazole	18 mg/mL, 16.7 mL vials	205596	1	2015-11-24
NOXAFIL	Delayed-release Tablets	posaconazole	100 mg	205053	1	2014-06-16
NOXAFIL	Oral Suspension	posaconazole	40 mg/mL	022003	1	2011-02-28

US Patents and Regulatory Information for NOXAFIL

NOXAFIL is protected by nine US patents and three FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes	9,023,790		Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes	9,493,582		Y
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes	10,117,951		Y
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013		DISCN	Yes	No
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013		DISCN	Yes	No
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes	9,358,297		Y

Expired US Patents for NOXAFIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	6,958,337
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013	5,703,079
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	5,661,151
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013	5,661,151
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	5,661,151
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	5,703,079
Schering	NOXAFIL	posaconazole	SUSPENSION;ORAL	022003-001	Sep 15, 2006	8,263,600

EU/EMA Drug Approvals for NOXAFIL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp and Dohme B.V	Noxafil	posaconazole	EMEA/H/C/000610 Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.	Authorised	no	no	no	2005-10-25
Accord Healthcare S.L.U.	Posaconazole AHCL	posaconazole	EMEA/H/C/005028 Posaconazole AHCL oral suspension is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole AHCL oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.	Authorised	yes	no	no	2019-07-25
Accord Healthcare S.L.U.	Posaconazole Accord	posaconazole	EMEA/H/C/005005 Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis;Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.	Authorised	yes	no	no	2019-07-25
Schering-Plough Europe	Posaconazole SP	posaconazole	EMEA/H/C/000611 Posaconazole SP is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.Posaconazole SP is also indicated for prophylaxis of invasive fungal infections in the following patients:- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who areat high risk of developing invasive fungal infections;- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.	Withdrawn	no	no	no	2005-10-25

International Patents for NOXAFIL

See the table below for patents covering NOXAFIL around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2008120836	ANTIFUNGAL COMPOSITION WITH ENHANCED BIOAVAILABILITY
Japan	6276828
Croatia	P20211686
Canada	2802929	FORMULATIONS D'UNE SOLUTION INTRAVEINEUSE DE POSACONAZOLE STABILISEES PAR UNE CYCLODEXTRINE BETA SUBSTITUEE (POSACONAZOLE INTRAVENOUS SOLUTION FORMULATIONS STABILIZED BY SUBSTITUTED BETA-CYCLODEXTRIN)
Colombia	4520281	ANTIFUNGICOS DE TETRAHIDROFURANO
World Intellectual Property Organization (WIPO)	2009134347
Russian Federation	2747757	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION)

Supplementary Protection Certificates for NOXAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0736030	300219	Netherlands		300219, 20141220, EXPIRES: 20191219
0736030	06C0009	France		PRODUCT NAME: POSACONAZOLE; REGISTRATION NO/DATE: EU/1/05/320/001 20051025
0736030	C00736030/01	Switzerland		FORMER OWNER: SCHERING CORPORATION, US
0736030	SPC003/2006	Ireland		SPC003/2006: 20061023, EXPIRES: 20191219
0736030	SPC/GB06/007	United Kingdom		PRODUCT NAME: POSACONAZOLE, OPTIONALLY IN THE FORM OF AN ESTER OR PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/05/320/001 20051025; UK EU/1/05/321/001 20051025
0736030	CA 2006 00002	Denmark
0736030	8/2006	Austria		PRODUCT NAME: POSACONAZOL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/05/320/001 EU/1/05/321/001 20051025

NOXAFIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NOXAFIL (Posaconazole)

Introduction to NOXAFIL (Posaconazole)

NOXAFIL, also known as posaconazole, is a triazole antifungal agent used for the treatment and prophylaxis of various fungal infections, including invasive aspergillosis and candidiasis. The drug is available in several formulations, including oral suspension, delayed-release tablets, and injection.

Global Market Size and Growth

The global posaconazole market, which includes NOXAFIL, was valued at USD 613.48 million in 2024 and is projected to reach USD 941.50 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.50% during the forecast period of 2025 to 2032[1].

Market Segmentation

The posaconazole market is segmented by type, application, end-users, and distribution channels.

By Type

• Injection
• Delayed-release Tablets
• Oral Suspension
• Others

By Application

• Prophylaxis of Invasive Aspergillus and Candida Infections
• Oropharyngeal Candidiasis (OPC)
• Invasive Infections by Candida, Mucor, and Aspergillus Species
• Other applications

By End-Users

• Clinics
• Hospitals
• Diagnostic Centers
• Others

By Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

Key Market Drivers

Growing Prevalence of Fungal Infections

The increasing prevalence of fungal infections, particularly among immunocompromised patients, is a significant driver of the posaconazole market. Regions such as North America and Asia-Pacific are experiencing a rise in these infections, which is fueling the demand for antifungal medications like NOXAFIL[1].

Expanding Healthcare Infrastructure

The growing healthcare infrastructure in emerging regions, including Asia-Pacific and Latin America, presents a substantial market opportunity. Governments in countries like India, China, and Brazil are investing heavily in expanding healthcare facilities, which includes increasing the availability of critical medications such as posaconazole[1].

Generic Formulations and Patient Compliance

Recent innovations have focused on improving the bioavailability and patient convenience of posaconazole. The launch of generic versions by companies like Dr. Reddy's Laboratories and Aurobindo Pharma has enhanced accessibility and patient compliance. For instance, Dr. Reddy's Laboratories launched posaconazole delayed-release tablets in the U.S. market, which are the therapeutic generic equivalent to NOXAFIL[4].

Market Trends

Shift Towards Generic Formulations

The growing shift towards generic formulations is a notable trend in the posaconazole market. Generic versions of NOXAFIL have been launched by several companies, which has increased competition and reduced costs, making the drug more accessible to a wider patient population[1].

Advancements in Clinical Research

Advancements in clinical research and government support for antifungal drug development are expected to further propel the market. Continued investment in R&D and expanding healthcare access are key factors driving the sustained growth of the posaconazole market[1].

Regional Market Analysis

North America

North America holds a dominant position in the posaconazole market, driven by the presence of leading pharmaceutical companies and well-established healthcare infrastructure. The U.S. and Canada are significant contributors to this market, with a high prevalence of fungal infections and a strong reliance on antifungal medications[1].

Asia-Pacific

The Asia-Pacific region is anticipated to experience significant growth during the forecast period. Government initiatives and support for healthcare infrastructure and innovation, along with rising investments in R&D activities in countries like China, India, and Japan, are driving the market expansion in this region[1].

Financial Performance and Revenue Projections

Current Market Value

The NOXAFIL brand and its generic equivalents had U.S. sales of approximately $140.8 million for the twelve months ending in February 2022[4].

Future Projections

The global posaconazole market is expected to grow from USD 613.48 million in 2024 to USD 941.50 million by 2032, indicating a robust financial trajectory. This growth is driven by increasing demand, expanding healthcare infrastructure, and the launch of new formulations[1].

Challenges and Opportunities

Side Effects and Safety Concerns

Despite the growth potential, the posaconazole market faces challenges related to side effects and safety concerns. These issues hinder broader adoption and push for the development of safer alternatives or improved formulations with fewer side effects[1].

Regulatory Framework

Government support and regulatory approvals play a crucial role in the market's growth. For instance, the U.S. FDA approval of generic versions of NOXAFIL has expanded market accessibility and competition[4].

Key Players and Market Competition

Major Market Players

Companies such as Merck (the original developer of NOXAFIL), Dr. Reddy's Laboratories, Aurobindo Pharma, and Fresenius Kabi are key players in the posaconazole market. These companies are investing in R&D, launching generic versions, and expanding their portfolios to include posaconazole-based therapies[1][4].

Competitive Landscape

The competitive landscape is characterized by the presence of both branded and generic versions of posaconazole. The entry of generic formulations has increased competition, reducing prices and making the drug more affordable for patients[1].

Conclusion

The posaconazole market, driven by the demand for NOXAFIL and its generic equivalents, is poised for sustained growth. Key drivers include the increasing prevalence of fungal infections, expanding healthcare infrastructure, and advancements in clinical research. Despite challenges related to side effects and safety concerns, the market is expected to reach USD 941.50 million by 2032, driven by robust growth in regions like North America and Asia-Pacific.

Key Takeaways

• The global posaconazole market is projected to grow from USD 613.48 million in 2024 to USD 941.50 million by 2032.
• The market is driven by the growing prevalence of fungal infections and expanding healthcare infrastructure.
• Generic formulations and patient compliance improvements are significant trends.
• North America and Asia-Pacific are key regions driving market growth.
• Side effects and safety concerns are major challenges.
• Government support and regulatory approvals are crucial for market growth.

FAQs

What is NOXAFIL used for?

NOXAFIL (posaconazole) is used for the treatment and prophylaxis of various fungal infections, including invasive aspergillosis and candidiasis.

What are the different formulations of NOXAFIL?

NOXAFIL is available in oral suspension, delayed-release tablets, and injection formulations.

Which regions are driving the growth of the posaconazole market?

North America and Asia-Pacific are the key regions driving the growth of the posaconazole market.

What are the major challenges in the posaconazole market?

The major challenges include side effects and safety concerns associated with posaconazole, which hinder its broader adoption.

Who are the key players in the posaconazole market?

Key players include Merck, Dr. Reddy's Laboratories, Aurobindo Pharma, and Fresenius Kabi.

Sources

1. Data Bridge Market Research: "Posaconazole Market Size, Scope & Industry Trends By 2032"
2. Markets Business Insider: "Ligand Pharma Poised for Growth: Analyst Recommends Buy on Strategic Investments and Revenue Projections"
3. ACS Publications: "Novel High-Drug-Loaded Amorphous Dispersion Tablets of Posaconazole"
4. BioSpace: "Dr. Reddy's Laboratories Announces the Launch of Posaconazole Delayed-Release Tablets in the U.S. Market"
5. FDA: "Noxafil (posaconazole) Label"