This comes following a previous announcement of the voluntary replacement of certain NATESTO lots available in Canada and South Korea markets.
Acerus Pharmaceuticals (TSX:ASP, OTCQB:ASPCF) has announced an update on the temporary unavailability of NATESTO in Canada and South Korea.
As quoted in the press release:
Acerus made minor modifications to the manufacturing process that appear to have resolved the previously identified issues and has produced a batch of NATESTO® (the “Revised Batch”). While Acerus believed the changes would have been classified by Health Canada as level III, thereby requiring only an annual notification update to Health Canada and allowing for product to be released in Q4-2019, Health Canada, after much deliberation, classified the modifications as level I, requiring the submission of a Supplemental New Drug Submission (“SNDS”) prior to the release of the Revised Batch in the Canadian market. In the event that Health Canada utilizes the full regulatory allotted time for reviewing a SNDS, Acerus would expect the Revised Batch to be released in the Canadian Market in Q1-2021. Acerus continues to work with Health Canada to facilitate an expeditious review of the SNDS and minimize market disruptions.
At this time, the current supply of NATESTO® to the United States is not affected by this situation. Acerus is working with its South Korean partner to determine whether the Revised Batch can be released in the South Korean market and, if so, under what timeframes.