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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 committee recommends approval of Valeant Pharma's brodalumab to treat moderate-to-severe plaque psoriasis

Valeant Pharmaceuticals International, Inc. announced that the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the US Food and... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=96388&sid=2
Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program

Synergy Pharmaceuticals Inc. today announced it has reached the Food and Drug Administration (FDA) mid-cycle review milestone for the plecanatide... ...

http://www.pharmaceutical-tech.com/pressreleases/synergy-pharmaceuticals-provides-update-on-ongoing-fda-review-of-plecanatide-cic-nda
DURECT's Abuse-Deterrent Opioid Poised for FDA Approval

SAN FRANCISCO, CA--(Marketwired - July 14, 2016) - Oxycodone is a powerful and lucrative painkiller, but one with serious downsides. Dependency on... ...

http://in.sys-con.com/node/3874196
Bausch + Lomb and Nicox Announce the Publication of Latanoprostene Bunod Ophthalmic Solution 0.024% Phase 3..

Second Published Phase 3 Trial to Demonstrate Significantly Greater Efficacy vs. Timolol Maleate 0.5% LAVAL, Quebec and SOPHIA ANTIPOLIS,... ...

http://in.advfn.com/p.php?pid=nmona&article=71899325
Takeda Submits a New Drug Application for Novel Oral Proteasome Inhibitor Ixazomib in Japan

Takeda Submits a New Drug Application for Novel, Oral Proteasome Inhibitor Ixazomib in Japan Tuesday, July 05, 2016 OSAKA, Japan--( BUSINESS... ...

http://www.asianhhm.com/pressreleases/takeda-submits-a-new-drug-application-for-novel-oral-proteasome-inhibitor-ixazomib-in-japan

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