Major Pharmaceuticals has put out a press release saying that they've been forced to shut down all desiccated thyroid production. They received notice from the FDA that their complete line of natural desiccated thyroid drugs can no longer be manufactured, and that the FDA is pulling the designation that allowed them to sell these drugs.
Major is also saying that the FDA is requiring that all manufacturers that wish to continue manufacturing submit an NDA — New Drug Application — or Abbreviated New Drug Application (ANDA) for approval.
So we have no Biotech, no Major, no TimeCap Labs, a severe shortage of the Thyroid USP raw material, no Armour -- with no date for Armour to be back on the market -- and no Nature-Throid/Westhroid -- with a 90-day date for Nature-Throid/Westhroid to be back on the market.
Has the FDA contacted RLC Labs and Forest regarding an NDA or ANDA for Nature-Throid and Westhroid?
Are we soon going to hear that Armour is never coming back on the market -- and that Forest is out of the natural desiccated thyroid business completely -- or, less likely, is filing an NDA or ANDA? Are we going to hear that RLC is out of the NDT business, or filing an NDA or ANDA that could take years for approval?
RLC and Forest are the last players in the natural desiccated thyroid business in the U.S.
I have a call into the FDA -- the spokesperson there said she'd have to get more info and "get back to me" -- not holding my breath -- but she said that while they can't talk about NDAs (since when?) -- the requirement for natural dessicated thyroid to go through an NDA is "probably part of the unapproved drugs initiative."
Is it the end of the line for natural desiccated thyroid drugs?