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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 priority review status to Celgene's ABRAXANE sNDA to treat advanced pancreatic cancer

Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, has received the Priority Review designation from US Food and Drug... ...

http://www.pharmabiz.com/NewsDetails.aspx?aid=75528&sid=2

Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures

Global Study Advances Upsher-Smith's CNS Pipeline PR Newswire MAPLE GROVE, Minn., May 22, 2013 /PRNewswire/ --Upsher-Smith Laboratories, Inc. today... ...

http://www.asianhhm.com/news/news_archives.asp?NewsID=46062&title=UpsherSmith-Successfully-Completes-Phase-III-Study-Of-USL255-ExtendedRelease-Topiramate-For-Adjunctive-Treatment-Of-Epilepsy-In-Patients-With-Refractory-PartialOnset-Seizures

FDA Sets 17 July 2013 For MOXDUO Advisory Committee Meeting

For MOXDUO® Advisory Committee Meeting SYDNEY and BEDMINSTER, N.J., May 17, 2013 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY)... ...

http://www.andhranews.net/Intl/Web/2-38.asp

KYTHERA Biopharmaceuticals Announces First Quarter 2013 Operating Results

(GLOBE NEWSWIRE) -- KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today reported financial results for its first quarter 2013, and provided an... ...

http://www.bizwireexpress.com/showstoryGNW.php?storyid=310077

Actavis' NDA for Progestin-Only Patch Accepted for Filing by FDA

/PRNewswire/ --Actavis, Inc. (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug... ...

http://www.asianhhm.com/news/news_archives.asp?NewsID=44944

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