Product Proposed Indication Development Stage

Bendamustine RTD
30 or 60 minutes IV infusion in 500 mL admixture

  • Chronic lymphocytic leukemia (CLL)
  • Indolent B-cell non-Hodgkin’s lymphoma (NHL)

NDA tentatively approved in July 2014

RTU bivalirudin

Ready-to-use version of Angiomax®

For use as an anticoagulant in patients:

  • Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI)
  • With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI
  • With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA)

NDA filed

RYANODEX®
(dantrolene sodium) for injectable suspension

  • Exertional heat stroke (EHS)

Phase 2
FDA ODD granted
Fast Track Designation

Pemetrexed
liquid version of Alimta®

  • Locally advanced or metastatic nonsquamous non-small cell lung cancer
  • Mesothelioma

Pre-clinical

IV=intravenous; RTD=ready-to-dilute; RTU=ready-to-use; ODD=orphan drug designation.

Angiomax® is a registered trademark of The Medicines Company.
Alimta® is a registered trademark of Eli Lily and Company.

Oncology

Ready-to-Dilute (RTD) Bendamustine Hydrochloride

Eagle RTD bendamustine hydrochloride (HCl) is a ready-to-dilute liquid in a multi-dose vial being developed to provide extended drug stability over other bendamustine HCl liquid products for use with a 500 mL IV bag.

Proposed Indication

Chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL)

Pemetrexed

Eagle pemetrexed is designed to be a ready-to-dilute (RTD) liquid of 500 mg in a multi-dose vial.

Proposed Indication

Eagle pemetrexed is being developed for the treatment of locally advanced or metastatic non-small cell lung cancer and mesothelioma.

Critical Care

Bivalirudin

Eagle bivalirudin is designed to be a ready-to-use (RTU) liquid formulation of bivalirudin in a (5 mg/mL) 50-mL vial that could be administered to patients without having to reconstitute the drug.

Proposed Indications

Percutaneous Transluminal Coronary Angioplasty (PTCA)
The branded reference drug, Angiomax® (bivalirudin) is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).15

Percutaneous Coronary Intervention (PCI)
Angiomax with provisional use of glycoprotein IIb/IIIa inhibitor (GPI), as listed in the REPLACE-2 trials, is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).15

Angiomax is indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI.15

Use With Aspirin
Angiomax in these indications would be intended for use with aspirin and has been studied only in patients receiving concomitant aspirin.15

Limitations of Use
The safety and effectiveness of Angiomax have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.15

RYANODEX® (dantrolene sodium) for injectable suspension will be further developed for additional indications.

RYANODEX® is a vial containing 250 mg of dantrolene sodium in lyophilized powder form for injectable suspension. It requires 5 mL of sterile water for reconstitution.9

Proposed Indication

RYANODEX® is being evaluated for the treatment of exertional heatstroke in conjunction with appropriate supportive measures.