GSK Regulatory Update: Avodart

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GSK Regulatory Update: Avodart

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Tags: Cancer, Cancer Prevention, Prostate Cancer, Prostate, Benign Prostatic Hypertrophy Medication, Men's Health, Avodart, GlaxoSmithKline

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Most Recently Shared on November 23, 2009 at 3:11 pm By:

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GSK withdraws sNDA for Avodart for prostate cancer prevention http://ow.ly/ET4W

2 years ago...

Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccine

us.gsk.com — “Regulatory Update: GlaxoSmithKline submits additional information for candidate meningococcal and Hib combination vaccineView full resource at us.gsk.com

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Most Recently Shared on December 1, 2011 at 3:46 pm By:

eyeonfda eyeonfda Pharma and Health Lawyer

GSK submits additional info to FDA for candidate meningococcal and Hib combination vaccine http://t.co/7O2I9g7m

5 months ago...

Regulatory Update: GSK and XenoPort submit supplemental New Drug Application to FDA for Horizant™ in postherpetic neuralgia

us.gsk.com — “Regulatory Update: GSK and XenoPort submit supplemental New Drug Application to FDA for Horizant™ in postherpetic neuralgiaView full resource at us.gsk.com

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Most Recently Shared on August 10, 2011 at 1:10 pm By:

eyeonfda eyeonfda Pharma and Health Lawyer

GSK and XenoPort submit supplemental NDA to #FDA for Horizant™ in postherpetic #neuralgia http://ow.ly/5ZEGt

8 months ago...

GlaxoSmithKline European Regulatory Update on Pandemrix - Drugs.com MedNews

drugs.com — “Issued Thursday 21 July 2011, London UK GlaxoSmithKline (GSK) announced today that the European Medicines Agency s (EMA) Committee for Medicinal Products for HuView full resource at drugs.com

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Most Recently Shared on July 22, 2011 at 2:04 pm By:

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GlaxoSmithKline European Regulatory Update on Pandemrix: Issued: Thursday 21 July 2011, London UK GlaxoSmi... http://bit.ly/nb2qbq #drug

9 months ago...

GlaxoSmithKline European regulatory update on Pandemrix™

gsk.com — “GlaxoSmithKline European regulatory update on Pandemrix™View full resource at gsk.com

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Most Recently Shared on July 21, 2011 at 9:09 pm By:

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GlaxoSmithKline European regulatory update on Pandemrixâ„¢: GlaxoSmithKline (GSK) announced today that the Europ... http://bit.ly/pZzs2y

9 months ago...

Regulatory update -- GSK and Valeant respond to FDA on ezogabine

us.gsk.com — “Regulatory update -- GSK and Valeant respond to FDA on ezogabineView full resource at us.gsk.com

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Most Recently Shared on April 18, 2011 at 1:16 pm By:

eyeonfda eyeonfda Pharma and Health Lawyer

GSK and Valeant Pharmaceuticals submit response to FDA CRL for ezogabine NDA http://ow.ly/4CraX

12 months ago...

GlaxoSmithKline drops Avodart for prostate cancer risk reduction - Pharmaceutical and Biotechnology News - Pharma Letter

thepharmaletter.com — “UK pharma giant GlaxoSmithKline (LSE: GSK) says that it will no longer pursue global approval for the use of Avodart (dutasteride) to reduce the risk of prostate cancer. The company will withdraw applications from regulatory review where procedures are onView full resource at thepharmaletter.com

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Most Recently Shared on March 24, 2011 at 5:35 pm By:

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GlaxoSmithKline drops Avodart for prostate cancer risk reduction http://bit.ly/gRCa25

1 year ago...

GSK scraps plans to market prostate-cancer drug | The Associated Press | News | Washington Examiner

washingtonexaminer.com — “Drug giant GlaxoSmithKline PLC says it will no longer pursue global regulatory approval to market its Avodart drug to treat prostate cancer following negative feedback from American and Swedish regulators. Avodart is approved in more than 90 countries to treat an enlarged prostate.View full resource at washingtonexaminer.com

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Most Recently Shared on March 23, 2011 at 11:47 pm By:

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GSK scraps plans to market prostate-cancer drug | The Associated ... http://bit.ly/eyOgBn

1 year ago...

GSK scraps plans to market prostate-cancer drug

health.yahoo.net — “Drug giant GlaxoSmithKline PLC says it will no longer pursue global regulatory approval to market its Avodart drug to treat prostate cancer following negative feedback from American and Swedish regulators.View full resource at health.yahoo.net

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Most Recently Shared on March 23, 2011 at 4:40 pm By:

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GSK scraps plans to market prostate-cancer drug http://bit.ly/hQd6cL

1 year ago...

Regulatory update: Nimenrix® (MenACWY vaccine)

gsk.com — “GlaxoSmithKline (GSK) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for its candidate conjugate meningitis vaccine, Nimenrix®,View full resource at gsk.com

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Most Recently Shared on March 2, 2011 at 2:49 pm By:

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GSK submits Marketing Authorisation Application (MAA) to EMA for candidate conjugate meningitis vaccine, Nimenrix® - http://ow.ly/46mkF

1 year ago...

Avodart Reviewed By FDA Advisory Committee For Prostate Cancer Risk Reduction

medicalnewstoday.com — “GlaxoSmithKline (NYSE: GSK) announced the results of a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the supplemental New Drug Application (sView full resource at medicalnewstoday.com

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Most Recently Shared on December 2, 2010 at 3:37 pm By:

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Avodart Reviewed By FDA Advisory Committee For Prostate Cancer Risk Reduction GlaxoSmithKline (NYSE: GSK) announced the.. http://dld.bz/8Wrf

1 year ago...

GSK Regulatory Update On Avandia Following EMA And FDA Reviews

medicalnewstoday.com — “GlaxoSmithKline (NYSE and LSE: GSK) confirms that following a review of Avandia® (rosiglitazone maleate) by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), eView full resource at medicalnewstoday.com

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Most Recently Shared on September 24, 2010 at 8:05 pm By:

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GSK Regulatory Update On Avandia Following EMA And FDA Reviews http://mnt.to/3Khv #regulatory

2 years ago...

GSK EU regulatory update on Avandia (rosiglitazone)

gsk.com — “GSK EU regulatory update on Avandia (rosiglitazone)View full resource at gsk.com

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Most Recently Shared on July 9, 2010 at 2:14 pm By:

eyeonfda eyeonfda Pharma and Health Lawyer

EMA sets meeting to review benefit/risk profile of Avandia - http://ow.ly/29dIy

2 years ago...

Regulatory update - Benlysta (belimumab)

gsk.com — “Regulatory update - Benlysta (belimumab)View full resource at gsk.com

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Most Recently Shared on June 7, 2010 at 1:11 pm By:

eyeonfda eyeonfda Pharma and Health Lawyer

GSK files MAA 2 EMA 4 Benlysta (belimumab) 4 reducing disease activity in lupus patients receiving standardtherapy http://ow.ly/1V1Fb

2 years ago...

GSK Regulatory Update Avodart (dutasteride)

medicalnewstoday.com — “GlaxoSmithKline (NYSE: GSK) announced that it has re-submitted the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increaseView full resource at medicalnewstoday.com

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Most Recently Shared on March 30, 2010 at 2:07 pm By:

Updated GlaxoSmithKline statement on European regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine)

gsk.com — “not namedView full resource at gsk.com

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Most Recently Shared on March 26, 2010 at 3:23 pm By:

eyeonfda eyeonfda Pharma and Health Lawyer

Updated GSK statement on EU regulatory guidance relating to manufacture of Rotarix (rotavirus vaccine) - http://ow.ly/1rgbR

2 years ago...

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