Rockwell generic vitamin D cleared for sale

The FDA approves Rockwell Medical's (RMTI +5.8%) ANDA to manufacture Calcitrol, a low cost generic vitamin D drug. Calcitrol injection is indicated for the management of hypocalcemia in patients undergoing chronic renal dialysis.

Chief Robert L Chioini says, "Achieving this FDA approval is a significant achievement for Rockwell and its enables us to execute on our strategic initiative to begin selling Calcitrol in the renal market where the CMS bundled-reimbursement payment system has incentivized dialysis service providers to utilize the lowest cost drugs."

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Comments (2)
  • Blue22
    , contributor
    Comments (449) | Send Message
    Another wait by the FDA? Every study, test presentations for peer reviews, etc are done as usual Rockwell's miracle drug Triferic, approved months ago, will have to wait until 2015! It is in demand around the World right now and to hold it longer will cost at least $700 million. Why?


    Even the two other companies in the dialysis field are involved in this wonder drug. It was quite difficult to control the iron levels during a dialysis treatment, but the problem is solved. There is a huge market for Triferic and Rockwell certainly needs to see some clear profits to move on to the next research.
    24 Jun 2014, 11:57 AM Reply Like
  • outofhere
    , contributor
    Comments (3694) | Send Message
    blue 22


    I'm lost by your comment, Calcitrol is a calcium based drug while Triferic is an iron based drug. And the two perform separate functions. Am I wrong?
    28 Jun 2014, 02:44 PM Reply Like
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