UPDATE: Dantrolene supply compromise

The supply of Dantrolene (Dantrium) is compromised. ANZCA has asked the TGA to expedite licensing of alternative brands.
Pfizer has communicated the following:
  • Imminent out of stock of Dantrium IV.
  • Current expiry of in-market stock is March 31, 2017.
  • Next delivery of Dantrium IV mid-May.
  • TGA have been informed and S19a application has been lodged by Pfizer.
  • Trying to bring in the stock to alleviate 6000 vial gap, either via SAS and or 19a exemption from TGA.
    • 2400 expected to arrive  (UK stock) in about two weeks.
    • Need to have a distribution strategy to ensure rapid access when needed.
  • CATAG members agreed stock should be distributed proportionally to all jurisdictions according to previous ordering.
ANZCA has requested the TGA to expedite licensing of alternative brands of dantrolene.

Pfizer has advised that supply interruption is due to an unexpected manufacturing delay for DANTRIUM® (dantrolene sodium) powder for injection 20 mg vials. There are no safety concerns with the above product.

Pfizer is sourcing an alternative product in place of the Australian registered product during this out of stock period. This action is being taken in consultation with the Therapeutic Goods Administration (TGA). For more information see here.
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