Amneal obtains FDA nod for Pemrydi RTU

The Food and Drug Administration has approved Amneal’s Pemrydi RTU, the 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: 100 mg/10 ml; 500 mg/50 ml; and 1,000 mg/100 ml. The company expects to launch the 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, said Harsher Singh, senior vice president of Amneal Biosciences. "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.”

[Read more: Amneal touts 26 generic new product launches in 2022]

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 who are otherwise not candidates for curative surgery.

[Read more: Amneal debuts 2 generics]

Pemetrexed had a market value of $532 million, for the 12 months ended March 2023, according to IQVIA.