After meeting with the FDA regarding the clinical program for US approval of its Penthrox methoxyflurane inhaler, Medical Developments International (MVP) said that it expects to receive a clinical hold letter from the agency within the next two months.
Penthrox is currently approved for the treatment of pain in numerous countries, including Canada, and much of Europe, with new approvals in Portugal, Switzerland, Italy, the Czech Republic, and Spain in the past two months.
MVP CEO John Sharman commented, “This setback in our timetable to have Penthrox approved for sale in the US is very disappointing. We must now wait and see what the FDA require us to do, in addition to the work we have already done.”
Read the MVP press release.
