Pharmaxis said that its distribution partner Methapharm Inc. has begun selling Pharmaxis’ Aridol mannitol bronchial challenge test kit again in the United States. According to the company, its Sydney, Australia manufacturing facility received FDA approval to manufacture Aridol for the US market in August 2018.
Aridol is also approved in Australia, South Korea, and a number of European countries. The Aridol test kit includes a capsule-based dry powder inhaler and capsules containing five different doses of dry powder mannitol.
Pharmaxis CEO Gary Phillips said, “Aridol was approved by the FDA in 2011 to identify bronchial hyperresponsiveness and commercialized by Pharmaxis in the US until its withdrawal from the market in 2013 as part of a corporate restructuring when we closed the facility used to manufacture Aridol for the US. Two years ago Pharmaxis partnered with Methapharm to re‐enter the US market and commenced the validation work required to have our remaining manufacturing facility approved by the FDA for Aridol. Both Methapharm and Pharmaxis believe there remains a strong need in the US for objective tests to aid physicians in diagnosing asthma. It’s good to be back.”
Read the Pharmaxis press release.
