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Based on the anticipated Prescription Drug User Fee Act (PDUFA) action date, the FDA approval is expected in the second quarter of 2015. The sNDA was based on

The company secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA)for Lamivudine Tablets to treat chronic hepatitis B virus

Based upon the COMP positive opinion, the commission will make a final decision on European orphan drug designation. BCX4161 is a selective inhibitor of plasma kallikrein and is

The Nucynta franchise includes Nucynta ER (tapentadol) extended release tablets that are designed to manage pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), and Nucynta (tapentadol),

If approved, Akorn’s ANDA product would be a generic version of Alcon’s Durezol(R), which is a topical corticosteroid indicated for the treatment of inflammation and pain associated with

Myalept is a recombinant human leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or

The data will be presented during a poster session at the 2015 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium taking place in San Francisco from January

The study assessed BRILINTA (ticagrelor) tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who

As part of the agreement, Vical will develop and provide a DNA vaccine encoding the glycoprotein antigen of the 2014 Zaire strain of Ebola virus to AnGes, which