Approvable Letter Update

J0385349While it seems that the rate for approvable letters has slowed down over last year, it is nevertheless brisk and I’ve been a bit remiss on keeping up to date.  As noted recently, the FDA has acknowledged that it will be slowing down approvals and it probably isn’t prudent to expect this trend to end during 2008. 

In addition to approvable letters issued, Labopharm has heard an outcome to the company’s curious and determined appeals to an FDA earlier decision to issue an approvable letter for its application for Tramadol.  As one might expect, the appeal was not granted.   According to the company’s statement in their press release – "Procedurally, Dr. Douglas Throckmorton, M.D., the FDA’s Deputy Director, Center for Drug Evaluation and Research, agreed with Dr. Jenkins, M.D., Director for the Office of New Drugs, Center for Drug Evaluation and Research and denied the appeal. However, he suggested a regulatory path forward. Dr. Throckmorton has suggested that the Company submit the analysis put forward by Dr. Jenkins in his letter of earlier this year."  The company now plans to respond by the end of the week. 

Now we know where the appeal process can get you.  In the meantime:

  • Merck & Co., Inc Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL® in Women Ages 27 through 45 – The company announced on June 25 that a CRL (also known as an "approvable letter") that stated "there are issues that preclude approval of the supplement within the expected review timeframe."   The response also referred to the sBLA for the use of compound against non-vaccine types (cross protection) and stated that "the data submitted do not support extending the indication for GARDASIL to include non-vaccine HPV types."  The company did not say what obstacles stood in the way of the approval of use in older women and that they would be submitting a response in July. 
  • Indevus Receives Approvable LetterThe company announced on June 30 that it had received an approvable letter for  NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism.  The press release stated that the FDA was asking the company to respond to "clinical deficiencies" related to the product – which is vague to say the least.  Specifically, the release said, that the agency has requested the FDA has requested follow-up data from on-going U.S. and European studies in which patients are being treated with NEBIDO on an extended basis and most of which will be completed within a year.
  • Akorn Gets Approvable Letter on June 6 for Akton Opththalmic Gel – The company announced the receipt of an FDA approvable letter for Akten® Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product that identified what were referred to as "several minor CMC deficiencies" and stated that a response will be submitted to the FDA within ten days and that no additional clinical data is required.  No further press release was issued to say that the company had submitted the response.


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