- Novel 505(b)(2) presentation of a key injectable for treating non-squamous non-small cell lung cancer and malignant pleural mesothelioma, does not require reconstitution, dilution, or refrigeration
- Amneal plans to launch two to three branded oncology 505(b)(2) products per year going forward – this is the first of 2024
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection. This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection.
“The launch of PEMRYDI RTU highlights Amneal’s deep commitment to oncology as we invest to develop injectable products that are important to healthcare providers and patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology. “In this first ready-to-use version, we offer hospitals and oncology clinics a new, value-added presentation that should improve pharmacy efficiency by eliminating preparation steps and freeing up refrigerator space with shelf stability for up to 24 months. We expect to launch two to three 505(b)(2) injectables per year going forward.”
PEMRYDI RTU® has a unique J-Code from the Centers for Medicare & Medicaid Services (CMS) to facilitate reimbursement: J9324: Injection, pemetrexed (pemrydi rtu). PEMRYDI RTU® injectable is available in two vial sizes: 100mg/10mL and 500 mg/50mL.
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 include myelosuppression, renal failure, skin toxicity, interstitial pneumonitis 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 February 2024 were $287 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 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
VP, Investor Relations & Media
anthony.dimeo@amneal.com
