FDA Accepts Eagle Pharma's Application for Lung Treatment

Eagle Pharmaceuticals’ pemetrexed NDA accepted for filing by the FDA.

Eagle Pharmaceuticals, Inc. announced that the 505(b)(2) New Drug Application (NDA) for its novel Pemetrexed Injection, 25 mg/mL has been accepted for filing by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of October 30, 2017 to complete its review of the NDA.

This 505(b)(2) NDA requests FDA approval of Eagle’s ready-to-dilute (RTD) Pemetrexed Injection 25 mg/mL product for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer, and mesothelioma (in combination with cisplatin).

“We are pleased that our Pemetrexed Injection NDA has been accepted for filing with the FDA. We look forward to the FDA’s decision in October 2017, and intend to work closely with the FDA through the review process,” stated Scott Tarriff, chief executive officer of Eagle Pharmaceuticals.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy, according to the company, is to utilize the FDA’s 505(b)(2) regulatory pathway.

(Source: Business Wire)