Amneal Receives NDA Approval from the US FDA for Pemrydi RTU

Share this

Amneal Receives NDA Approval from the US FDA for Pemrydi RTU


  • The US FDA has approved a 505(b)(2) NDA for Pemrydi RTU, the first ready-to-use presentation of pemetrexed indicated for use in combination with Keytruda and Pt-based CT for metastatic nonsq. NSCLC without EGFR or ALK tumor aberrations, and in combination with cisplatin for patients with malignant pleural mesothelioma
  • The inj. does not require reconstitution, dilution, or refrigeration. It will be available in three vial sizes: 100mg/10mL; 500mg/50mL; and 1000mg/100mL
  • Additionally, the company is expected to launch the product in Q1’24 with a J-Code from the Centers for Medicare & Medicaid Services

Ref: Businesswire | Image: Amneal

Related News:- Amneal Reports the Commercial Availability of Fylnetra (biosimilar, pegfilgrastim) in the US

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Click here to­ read the full press release 

Neha Madan

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions