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New rules for Indian generic drug makers

All generic drug makers, including Ranbaxy Laboratories, Cipla, Dr Reddy's Laboratories and Lupin, are now required to pay a fee to the US drug regulator while seeking permission to launch their......
  Web results for Pdufa
US FDA grants orphan drug status to Synthetic Biologics' SYN-005 to treat whooping cough

The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Synthetic Biologics' proprietary SYN-005 monoclonal antibody (mAb)... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=84065&sid=2
Amgen presents data from phase 3 SHIFT study evaluating ivabradine in patients with chronic HF at HFSA

Amgen announced data from the phase 3 SHIFT (Systolic Heart failure treatment with the If inhibitor ivabradine Trial) study evaluating ivabradine... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=84064&sid=2
FDA accepts Tuzistra XR (CCP-01) NDA for full review

From the Wires Sep. 15, 2014 07:44 AM MONMOUTH JUNCTION, N.J. , Sept. 15, 2014 /PRNewswire/ -- Vernalis plc (LSE: VER)and Tris Pharma,... ...

http://in.sys-con.com/node/3184459
Saxenda® for the treatment of obesity receives positive 14-1 vote in favor of approval from FDA Advisory Committee

From the Wires Sep. 11, 2014 08:50 PM WASHINGTON , Sept. 11, 2014 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and... ...

http://in.sys-con.com/node/3182799
US FDA accepts Actavis' NDA for ceftazidime-avibactam

Actavis confirmed that the US Food and Drug Administration (US FDA) has accepted for filing Actavis' application for ceftazidime-avibactam, its... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=83927&sid=2

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