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About 102 results for "gdufa"

FDAnews Announces — First Cycle Approval of ANDAs: The Journ...

Are drugmakers looking forward to a one cycle approval of an ANDA, now that GDUFA II is on its way? This webinar, presented by Dr. Aloka Srinivasan, former FDA Team Leader from Office of Generic Drugs, gives an overview of how drugmakers may want to ... MySanAntonio, 2 months ago

Hikma's ANDA for generic Advair Diskus accepted for filing by FDA

FDA has provided Hikma, through its wholly-owned subsidiary, West-Ward Pharmaceuticals, a GDUFA goal date of 10 May 2017. Hikma Pharmaceuticals has confirmed that its abbreviated new drug application (ANDA) for fluticasone propionate and ...
 CPhI.cn2 weeks ago HIKMA PHARMACEUTICALS : ANDA for Generic Advair Diskus accepted for filing by FDA  4 Traders2 weeks ago Vectura Group plc Portfolio Update - VR315 US  ADVFN UK3 weeks ago Hikma's ANDA accepted for filing by FDA  Stock Market Wire3 weeks ago

Teligent, Inc. Announces First Quarter 2016 Results

/PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey -based specialty generic pharmaceutical company, today announced its financial results for the first quarter ended March 31, 2016 . First Quarter 2016 Highlights Total revenues of $15.7 ...
 Barchart2 days ago Teligent Announces First Quarter 2016 Results  BioSpace2 days ago Teligent, Inc. Announces Fourth Quarter And Year-End 2015 Results  ProfitQuotes.com1 month ago Teligent Inc Announces Fourth Quarter And YearEnd 2015 Results  Asian Hospital & Healthcare Management1 month ago

Teligent's (TLGT) CEO Jason Grenfell-Gardner on Q1 2016 Results - Earnings Call Transcript

Teligent Incorporated (NASDAQ: TLGT ) Q1 2016 Earnings Conference Call April 28, 2016 16:15 ET Executives Jason Grenfell-Gardner - President & CEO Jenniffer Collins - CFO Analysts Matt Hewitt - Craig-Hallum Greg Gilbert - ...
 Seeking Alpha2 days ago Akorn's (AKRX) CEO Raj Rai on Business Update and 2016 Guidance Conference Call (Transcript)  Seeking Alpha1 month ago Hikma Pharmaceuticals' (HKMPF) CEO Said Darwazah on Q4 2015 Results - Earnings Call Transcript  Seeking Alpha1 month ago

Akorn's Macro-Level Challenges in the Generic Drug Segment

What Factors Are Driving Akorn's Valuations in 2016? ( Continued from Prior Part ) Generic drug segment According to the Generic Pharmaceutical Association, generic drugs accounted for about 88% of the total prescriptions but only 28% of the ...
 Yahoo! Finance UK and Ireland1 week ago
International Business Times India

India wins 14 key first-time generic drug approvals from USFDA in 2015

Of the 90 first-time generic drug approvals, 14 were awarded to Indian pharma companies in 2015 by drug regulator U.S Food and Drug Administration (USFDA). These approvals were for specialised treatments and belonged to Indian drug majors such as ...
 International Business Times India2 weeks ago Generic Topicort Ointment Approved  Pharmacy Times1 month ago

Amid harsh prescription, get-well card from US drug regulator

MUMBAI: While Indian companies have been getting the rough end of the stick from the US Food & Drug Administration (FDA) with a plethora of inspections and warning letters, the run of bad news may have drowned out some of the more positive developments. The ...
 Economic Times2 weeks ago

Despite being on rough end, annual report from US FDA's OGD shows Indian firms won key approvals in 2015

MUMBAI: While Indian companies have been getting the rough end of the stick from the US Food & Drug Administration (FDA) with a plethora of inspections and warning letters, the run of bad news may have drowned out some of the more positive ...
 Economic Times2 weeks ago

FDA Releases Annual Report on Generics

The Office of Generic Drugs highlights the agency's work to advance generic drugs. On April 13, 2016, FDA's Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER) released their first annual report . The report states ...
 PharmTech.com2 weeks ago 2015: An Important Year for Advancing Generic Drugs at FDA  PharmaceuticalProcessing2 weeks ago

Pharmaceutical & Medical Device Regulatory Update Vol. III, Issue 1

Top News Senate Confirms Califf as New FDA Commissioner After weeks of opposition, on February 24, 2016, the Senate confirmed Dr. Robert Califf, President Obama's nominee for FDA Commissioner . Although his nomination was not expected to be ...
 Lexology2 weeks ago
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