Azurity Pharmaceuticals Announces FDA Approval of Aprepitant Injectable Emulsion, Expanding Access to Critical Supportive Oncology Care

Ready-to-use formulation to help treatment preparation without the use of polysorbate-80

WOBURN, MA – June 25, 2026 – Azurity Pharmaceuticals, a global pharmaceutical company dedicated to redefining medicine for the real world, today announced that the U.S. Food and Drug Administration (FDA) has approved Aprepitant Injectable Emulsion, a practical, administration-friendly treatment option aimed at making the patient experience more manageable.

Aprepitant injections are in a class of medications called antiemetics. They work by blocking the action of neurokinin, a natural substance in the brain that causes nausea and vomiting. Aprepitant Injectable Emulsion, in combination with other antiemetic agents, is indicated in adults for the prevention of:

• Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC), including high-dose cisplatin as a single-dose regimen.
• Delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen.
• Nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.

Limitations of Use

• Aprepitant Injectable Emulsion has not been studied for the treatment of established nausea and vomiting.

Chemotherapy is often a debilitating experience that takes an overwhelming physical, emotional, and financial toll on patients and their families. Severe nausea and vomiting can be an additional hurdle they have to fight through.

“The FDA approval of Aprepitant Injectable Emulsion represents an important step in expanding access to supportive care options for patients receiving chemotherapy,” said Ronald L. Scarboro, Chief Executive Officer of Azurity Pharmaceuticals. “This ready-to-use formulation eliminates reconstitution and provides healthcare professionals with an additional antiemetic option that does not contain polysorbate-80. At Azurity, we are committed to applying our formulation science, regulatory expertise, and first-in-class enterprise model to optimize established therapies and deliver practical innovations that better align with the realities of patient care.”

The ready-to-use, intravenous (IV) formulation removes the need for reconstitution, reducing preparation steps for healthcare providers. Crucially, the formulation avoids polysorbate-80—a synthetic surfactant commonly found in other therapies that some patients may be sensitive to.

The FDA approval of Aprepitant Injectable Emulsion underscores the depth of Azurity’s scientific, regulatory, and intellectual property capabilities and further demonstrates the company’s ability to leverage the 505(b)(2) regulatory pathway to bring differentiated therapies to market efficiently. By applying clinical expertise, technology, and formulation science to optimize established medicines, Azurity develops practical innovations that improve ease of use and better align therapies with the realities of everyday patient care.

“At Azurity, we apply scientific, regulatory, and commercial expertise to deliver practical treatment options that address real-world healthcare needs,” said Chad Collins, Chief Commercial Officer, North America, Azurity Pharmaceuticals. “Aprepitant Injectable Emulsion expands the availability of a ready-to-use antiemetic option that may simplify preparation for healthcare providers and offers an additional treatment choice for patients receiving chemotherapy. By leveraging our multi-franchise model and development capabilities, we remain focused on bringing medicines to market efficiently and expanding access to therapies that can make a meaningful difference in patient care.”

IMPORTANT SAFETY INFORMATION

APREPITANT injectable emulsion, for intravenous use

Indications and Usage

Aprepitant Injectable Emulsion, in combination with other antiemetic agents, is indicated in adults for the prevention of:

• acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen.
• delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen.
• nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.
  Limitations of Use
• Aprepitant Injectable Emulsion has not been studied for the treatment of established nausea and vomiting.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Contraindications:

Aprepitant Injectable Emulsion is contraindicated in patients:

• who are hypersensitive to any component of the product [see Description (11)]. Hypersensitivity reactions including anaphylaxis have been reported [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].
• taking pimozide. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of pimozide, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see Warnings and Precautions (5.1)].

Warnings and Precautions:

Clinically Significant CYP3A4 Drug Interactions: Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4.

• Use of Aprepitant Injectable Emulsion with other drugs that are CYP3A4 substrates may result in increased plasma concentration of the concomitant drug.
  • Use of pimozide with Aprepitant Injectable Emulsion is contraindicated due to the risk of significantly increased plasma concentrations of pimozide, potentially resulting in prolongation of the QT interval, a known adverse reaction of pimozide [see Contraindications (4)].
• Use of Aprepitant Injectable Emulsion with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to Aprepitant Injectable Emulsion.
• Use of Aprepitant Injectable Emulsion with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of Aprepitant Injectable Emulsion.

See Table 8 and Table 9 in the Prescribing Information for a listing of potentially significant drug interactions [see Drug Interactions (7.1, 7.2)].

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis during or soon after administration of intravenous aprepitant have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus and wheezing have been reported [see Adverse Reactions (6.2)].

Monitor patients during and after administration. If hypersensitivity reactions occur, discontinue Aprepitant Injectable Emulsion and administer appropriate medical therapy. Do not reinitiate Aprepitant Injectable Emulsion in patients who experience these symptoms with previous use.

Decrease in INR with Concomitant Warfarin: Coadministration of aprepitant with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time [see Clinical Pharmacology (12.3)]. Monitor the INR in patients on chronic warfarin therapy in the 2-week period, particularly at 7 to 10 days, following initiation of Aprepitant Injectable Emulsion with each chemotherapy cycle [see Drug Interactions (7.1)].

Risk of Reduced Efficacy of Hormonal Contraceptives: Upon coadministration with aprepitant, the efficacy of hormonal contraceptives may be reduced during administration of and for 28 days following the last dose of aprepitant [see Clinical Pharmacology (12.3)]. Advise patients to use effective alternative or back-up methods of non-hormonal contraception during treatment with Aprepitant Injectable Emulsion and for 1 month following the last dose of Aprepitant Injectable Emulsion or oral aprepitant, whichever is administered last [see Drug Interactions (7.1), Use in Specific Populations (8.3)].

Adverse Reactions:

Most common adverse reactions are:

• Single-dose fosaprepitant with MEC (≥2%): fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity. (6.1)
• 3-day oral aprepitant with MEC (≥1% and greater than standard therapy): fatigue and eructation. (6.1)
• Single-dose fosaprepitant with HEC: generally similar to 3-day oral aprepitant. In addition, infusion site reactions (3%) occurred. (6.1)
• Single-dose intravenous aprepitant (≥2%): headache and fatigue. (6.1)

These are not all of the possible side effects of APREPITANT injectable emulsion. Please see Adverse Reaction (6) in the Prescribing Information for a full list.

Drug Interactions:

See full prescribing information for a list of clinically significant drug interactions. (4, 5.1, 5.3, 5.4, 7.1, 7.2)

Use in Specific Populations:

Pregnancy: May cause fetal harm. (8.1)

The Important Safety Information does not include all the information needed to use APREPITANT Injectable Emulsion safely and effectively. Please see accompanying full Prescribing Information for APREPITANT Injectable Emulsion.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

©2026 Azurity Pharmaceuticals, Inc.

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About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately held global pharmaceutical company dedicated to redefining medicine for the real world. Azurity’s first-in-class enterprise model challenges the status quo by rethinking how therapies are designed, delivered, and accessed. With more than 50 medicines across 10 therapeutic areas, Azurity’s mission is fueled by a growing portfolio that reaches millions of people in more than 50 countries. Learn more at www.azurity.com

Media Contact: media@azurity.com

©2026 Azurity Pharmaceuticals, Inc. All rights Reserved. This is intended for viewership in U.S. only. This press release may contain forward-looking statements subject to risks and uncertainties; actual results may differ materially.

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