Amneal Launches FOCINVEZ™, the First Ready-to-Use Version of Fosaprepitant

• FOCINVEZ (fosaprepitant) 150 mg/50 mL single dose vial is an anti-nausea agent for highly emetogenic and moderately emetogenic chemotherapy (HEC and MEC)
• Second injectable RTU product launched by Amneal in 2024

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the launch of FOCINVEZ™, a ready-to-use injectable. Unlike other versions of fosaprepitant, this single-dose vial product is free of Polysorbate 80 and does not require reconstitution or dilution and can be administered directly from the vial using the included vial hanger.

FOCINVEZ for injection is indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, 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, and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

“We continue to launch differentiated complex products that are clinically impactful,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “This is the second ready-to-use injectable we have launched this year that offers hospitals and oncology clinics a new presentation format that can improve pharmacy efficiency. These new 505(b)(2) injectables represent a new vector of growth for our expanding injectables portfolio.”

FOCINVEZ has a unique J-Code from the Centers for Medicare & Medicaid Services (CMS) to facilitate reimbursement: J1434, Injection, fosaprepitant (focinvez), 1 mg, and is available in one vial size 150mg/50mL (3mg/mL).

Adverse effects reported with FOCINVEZ include fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, and pain in extremity. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for fosaprepitant for the 12 months ended April 2024 were approximately $36 million.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

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Investor Contact

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.