Another Delay at the FDA…What’s Going On?

June 30, 2009 at 1:44 pm EST | Tags: , ,

Another PDUFA Delay at FDA...What's Going On?AMAG Pharmaceuticals‘ (AMAG) PDUFA date of June 29 for Feraheme came and went. And, without any news from the FDA, except that the agency would issue an action letter “within the next few days,” according to AMAG.

AMAG said that the FDA did not, however, require additional information and that a decision is expected in the coming days.

AMAG said this:

“It is the company’s understanding that there are no outstanding issues regarding the Feraheme New Drug Application.”

Back in May, the FDA told Hemispherx Biopharma (HEB) that it would need up to 1-2 additional weeks to take action on HEB’s Ampligen NDA. No follow up there either.

Two weeks ago, BioDelivery Sciences International (BDSI) said the FDA missed its June 12 PDUFA for Onsolis, but that a review team told BDSI they would not be issuing a review extension because the agency expects to “take action on the drug application soon.” Investors took the news positively though and shares shot up.

Last week, the FDA pushed back Acura Pharmaceuticals’ (ACUR) and King Pharmaceuticals’ (KG) June 30 PDUFA date for Acurox , but didn’t necessarily issue a complete response letter.

Which begs the question: What’s going on at the FDA?

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| AMAG’s Feraheme Gets Approval, So Does This Answer Our Question About the FDA? | Ready to Put Your Cash Back Into the Biotech Markets? | Hemispherx Biopharma Annual Stockholder Meeting Comes and Goes, but Still No FDA Update on Ampligen | D-Day for Denosumab: August 13th… | More Hemispherx Drama |


Comments

5 Responses to “Another Delay at the FDA…What’s Going On?”
  1. tantrix says:
    June 30, 2009 at 6:32 pm

    They’re tanning on the beaches ;)

  2. Roy Pope says:
    June 30, 2009 at 6:34 pm

    Articles like this are great for getting people to ask questions. Now, it’s time for getting those who can to give some answers. It is futile to contact the FDA for answers. Instead, the time is nigh that we turn to the most influential voice that we have to demand an answer – to contact the media (ABC 20/20, 60 minutes, etc) and to ask them to demand a response from the FDA.

  3. shane says:
    June 30, 2009 at 10:52 pm

    from what I heard on the news this morning they are focusing all their attention on the whole michael jackson cenerio,

  4. Jerremy,W says:
    June 30, 2009 at 11:02 pm

    They should realized that, people are dying and suffering every single minute, waiting to be cured. Stop the pain, start saving lifes and get back to work. God Bless America!!!

  5. Federal Delay Again says:
    July 13, 2009 at 10:48 pm

    FDA should be RE-EVALUATE…

    Can someone please report them or write a report to OBAMA Admin.

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