Amneal Receives 505(b)(2) NDA Approval from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable

– Adds first ready-to-use presentation of key injectable for treating non-squamous non-small cell lung cancer and malignant pleural mesothelioma

– Represents a high value, complex product launch for Amneal’s expanding injectable portfolio

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the 505(b)(2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration (“FDA”) for PEMRYDI RTU^®. This product is the first and only ready-to-use presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration. This injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL. The Company expects to launch this product in the first quarter of 2024 with a J-Code from the Centers for Medicare & Medicaid Services.

“We believe PEMRYDI RTU, the first ready-to-use version of a key oncology injectable, will offer a meaningful advantage in this improved presentation. By eliminating formulation steps common with other pemetrexed products, we are improving provider efficiencies while reducing the risk for medication errors. This approval represents another high-value product for our growing injectables portfolio which we expect to launch with a J-code for PEMRYDI RTU,” said Harsher Singh, SVP of Amneal Biosciences.

PEMRYDI RTU^® is indicated, in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberration and for initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

Adverse effects reported with PEMRYDI RTU^® include myelosuppression, renal failure, skin toxicity, and radiation recall. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for pemetrexed for the 12 months ended March 2023 were $532 million.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 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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Contacts

Anthony DiMeo

Head of Investor Relations

[email protected]