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Antares Pharma Inc. Message Board

  • dsr5152 dsr5152 Oct 7, 2013 7:48 PM Flag

    date changed frmOct 14th to Oct. 17th

    06/25/13-07/24/13 Merck Suvorexant Insomnia FDA Approval Decision
    7/26/2013 AVEO Pharmaceuticals Tivopath Renal Cell Cancer FDA Approval Decision
    7/26/2013 Forest Laboratories Levomilnacipran Depression FDA Approval Decision
    05/01/13-08/31/13 Ariad Pharmaceuticals Iclusig Acute Lymphocytic Leukemia EMA CHMP Panel Result
    02/01/13-08/31/13 Celgene Pomalyst Multiple Myeloma EMA CHMP Panel Result
    9/6/2013 Auxilium Pharmaceuticals Xiaflex Peyronie's Disease FDA Approval Decision
    10/17/2013 Antares Pharma Otrexup Rheumatoid Arthritis FDA Approval Decision
    10/22/2013 Actelion Opsumit Pulmonary Arterial Hypertension FDA Approval Decision
    10/24/2013 AMAG Pharmaceuticals Feraheme Anemia FDA Approval Decision
    12/17/2013 GlaxoSmithKline Dolutegravir HIV / AIDS FDA Approval Decision

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    • Oct. 14th is only an estimated date. I have been following this company fro awhile. Otrexup has a better than 95 percent chance of FDA approval next week. We may see a postmarketing surveillance program to periodically update the label. All the research is pointing to approval of Otrexup. There is really not much more information the FDA can get from ATRS at this point. The FDA can also use other sources and inputs to base its decision on. All the research is pointing approval and there is already plenty information for the labeling of the drug.

    • dsr5152, what is your source?? I see no change noted from the FDA. Also from your list above, AUXL's date was changed from 9/6/2013 to 12/6/2013

      FDA Calendar

      Source: PDUFADate putthedotin cominski

      Advisory Committee and PDUFA Date Activity
      Show entriesSearch:

      GENERIC NAME TRADE NAME ORIGINATOR INDICATION DATE

      paclitaxel protein-bound ABRAXANE Celgene Corporation advanced pancreatic cancer 09/21/2013 PDUFA

      Bazedoxifene/Conjugated estrogens or BZA/CE Duavive (EU) Aprela Ligand Pharmaceuticals Inc symptoms associated with menopause and prevention of osteoporosis 10/03/2013 PDUFA

      methotrexate sodium OTREXUP Antares Pharma Inc. rheumatoid arthritis 10/14/2013 PDUFA

      Icosapent ethyl Vascepa Amarin Corp Plc high triglycerides (TG =200 mg/dL and

      • 3 Replies to jab91252
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      • methotrexate sodium OTREXUP Antares Pharma Inc. rheumatoid arthritis 10/14/2013 PDUFA

      • Also, google: PDUFA Calendar » FDA Tracker.

        It shows no change. BUT, Monday the 14th is a Holiday, so I'm planning simply for the week of the 14th.

        Sentiment: Strong Buy

    • what is source for this info? this is news to me...

    • I don't know if this was due to the holiday or the government shutdown

 
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