Pharma Focus America

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

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has announced the approval of PEMRYDI RTU® under a 505(b)(2) New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA). This innovative product is the first of its kind as a ready-to-use presentation of pemetrexed for injection, eliminating the need for reconstitution, dilution, or refrigeration. PEMRYDI RTU® will be available in three vial sizes: 100mg/10mL, 500mg/50mL, and 1,000mg/100mL. The launch of this injectable is expected in the first quarter of 2024, accompanied by a J-Code assigned by the Centers for Medicare & Medicaid Services.

By offering a ready-to-use version of this important oncology injectable, PEMRYDI RTU® aims to provide significant benefits. It improves efficiency for healthcare providers by eliminating common formulation steps, reducing the risk of medication errors. This FDA approval further expands Amneal's injectables portfolio, adding a high-value product.

Indicated uses for PEMRYDI RTU® include its combination with pembrolizumab and platinum chemotherapy as the initial treatment for metastatic non-squamous non-small cell lung cancer patients without EGFR or ALK genomic tumor aberrations. It is also indicated for the initial treatment, in combination with cisplatin, of patients with unresectable malignant pleural mesothelioma or those ineligible for curative surgery.

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