Three Approvable Letters Issued This Week

J0409617 Not all companies are getting what they want for Christmas.  Taking on the form of the FDA, Santa has left a lump of coal in some corporate stockings when approvable letters were issued to three companies.  Remember that receipt of an approvable letter means that the FDA has some outstanding issues that need to be resolved before an approval can be issued.  These outstanding issues can be quite complex, involving a great deal of time and investment, such as new clinical trials, or relatively simple, such as a label adjustment or a manufacturing process issue.  In any case, it means a delay, either slight or lengthy, in getting to market. 

  • New River Pharmaceuticals and Shire - A second approvable letter was issued to these two companies for a treatment for Attention Deficit Hyperactivity Disorder (ADHD).  The first approvable letter was issued on October 6, 2006 and the company speedily submitted a response on October 24, 2006.  According to Yahoo Finance, the FDA is not requesting new studies.
  • Allergan Receives Approvable LetterAllergan or Irvine, California, announced an approvable letter for its product for COMBIGAN, a treatment for patients with glaucoma experiencing elevated intraocular pressure.  The release states that an additional confirmatory study is being requested by the agency and a quote from the Executive Vice President of Research and Development states that the study has already been underway. 
  • Generic Omeprazole DelayedPerrigo announced that it received an approvable letter for a generic version of omeprazole.  There was no word on the cause of the approvable letter or what conditions the FDA is seeking prior to approval.  If eventually approved, however, the generic version of omeprazole, a compound now marketed by Procter & Gamble as Prilosec OTC, would be the first. 

I did say yesterday, Eye on FDA would be on hiatus.  But I woke up to see 3 new approvable letters this morning and felt compelled to let you know about them.

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