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eyeonfda.com – Eye on FDA | RX for Pharma Industry Communications and Planning

OPDP Letters for Promotion of Investigational Compounds, Part 2 20 Aug 2013 | 07:01 pm

In my last posting, I provided an overview from my database of Warning and Untitled (NOV) letters data base that spans the years 2004 – present regarding FDA actions around communications perceived by...

Weekly Roundup – 8-16-13 16 Aug 2013 | 09:13 pm

Oh sweet summer!  The tomatoes hang heavy on the vines, hopefully out of reach of greedy little critters.  The peaches and plums are deliciously ripe.  It is almost time to put in a second batch of ba...

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PE Pill gets a No-Go from the FDA, at least for Now tongue-untied.bloghi.com 27 Oct 2005 | 07:22 pm

Mountain View, Calif., October 26, 2005) – ALZA Corporation announced today that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) on their New Drug Application ...

CorMedix Receives SPA from FDA for Deferiprone Phase 3 trial emergingbiotechs.com 25 Jun 2011 | 04:24 am

CorMedix (AMEX: CRMD) announced that it received a Special Protocol Assessment approval letter from the FDA on the design of a pivotal Phase 3 trial for Deferiprone. Deferiprone is indicated for Contr...

Vague Pharmaceutical Imprints pharmer.org 10 Jul 2005 | 09:25 am

Updated 04-27-12 All FDA approved pharmaceuticals must have a unique imprint. An imprint is any marking on the pill such as an engraved logo, numbers and/or letters, or a raised or debossed symbol. S...

Supernus Receives Tentative Approval of Trokendi XR(TM) From FDA crwenewswire.com.ar 27 Jun 2012 | 06:09 am

ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administrati...

Supernus Receives Tentative Approval of Trokendi XR(TM) From FDA crwenewswire.co.nz 27 Jun 2012 | 06:09 am

ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administrati...

Supernus Receives Tentative Approval of Trokendi XR(TM) From FDA crwenewswire.com.br 27 Jun 2012 | 06:09 am

ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administrati...

Supernus Receives Tentative Approval of Trokendi XR(TM) From FDA crwenewswire.sg 27 Jun 2012 | 06:10 am

ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administrati...

Supernus Receives Tentative Approval of Trokendi XR(TM) From FDA crwenewswire.my 27 Jun 2012 | 06:10 am

ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administrati...

Supernus Receives Tentative Approval of Trokendi XR(TM) From FDA crwenewswire.ae 27 Jun 2012 | 06:09 am

ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administrati...

Supernus Receives Tentative Approval of Trokendi XR(TM) From FDA crwenewswire.co.za 27 Jun 2012 | 06:09 am

ROCKVILLE, Md., June 26, 2012 (CRWENewswire) — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceuticals company, received a tentative approval letter from the Food & Drug Administrati...

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