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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
TEMPORARY UNAVAILABILITY OF NATESTO® IN CANADA AND SOUTH KOREA
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<blockquote data-quote="madman" data-source="post: 162190" data-attributes="member: 13851"><p><span style="font-size: 26px"><strong>ACERUS PROVIDES UPDATE ON TEMPORARY UNAVAILABILITY OF NATESTO® IN CANADA AND SOUTH KOREA</strong></span></p><p></p><p><span style="color: rgb(184, 49, 47)">11/01/2019</span></p><p></p><p><a href="http://www.aceruspharma.com/English/news/press-release-details/2019/Acerus-Provides-Update-on-Temporary-Unavailability-of-NATESTO-in-Canada-and-South-Korea/default.aspx" target="_blank">Acerus Pharmaceuticals Corporation - Acerus Provides Update on Temporary Unavailability of NATESTO® in Canada and South Korea</a></p><p></p><p></p><p></p><p></p><p><span style="color: rgb(26, 188, 156)"><strong>Current NATESTO® supply to the United States remains unaffected</strong></span></p><p></p><p><strong>TORONTO--(BUSINESS WIRE)-- <span style="color: rgb(184, 49, 47)"><em>Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today provided an update on the temporary unavailability of NATESTO® in Canada and South Korea, following the <u>previous announcement of the voluntary replacement of certain NATESTO® lots released</u> on the Canadian and South Korean markets.</em></span></strong></p><p></p><p><span style="color: rgb(0, 0, 0)"><strong><em>Acerus made <u>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”)</u>. 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, </em></strong></span><span style="color: rgb(184, 49, 47)"><em><strong><u>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</u>. In the event that Health Canada utilizes the full regulatory allotted time for reviewing a SNDS, </strong></em></span><span style="color: rgb(41, 105, 176)"><em><strong>Acerus would expect the Revised Batch to be released in the Canadian Market in Q1-2021.</strong></em></span><em> <strong><u>Acerus continues to work with Health Canada to facilitate an expeditious review of the SNDS and minimize market disruptions</u>.</strong></em></p><p><em></em></p><p><span style="color: rgb(26, 188, 156)"><em><strong>At this time, the current supply of NATESTO® to the United States is not affected by this situation</strong></em></span><em>. </em><span style="color: rgb(184, 49, 47)"><strong><em><u>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</u></em>.</strong></span></p></blockquote><p></p>
[QUOTE="madman, post: 162190, member: 13851"] [SIZE=26px][B]ACERUS PROVIDES UPDATE ON TEMPORARY UNAVAILABILITY OF NATESTO® IN CANADA AND SOUTH KOREA[/B][/SIZE] [COLOR=rgb(184, 49, 47)]11/01/2019[/COLOR] [URL='http://www.aceruspharma.com/English/news/press-release-details/2019/Acerus-Provides-Update-on-Temporary-Unavailability-of-NATESTO-in-Canada-and-South-Korea/default.aspx']Acerus Pharmaceuticals Corporation - Acerus Provides Update on Temporary Unavailability of NATESTO® in Canada and South Korea[/URL] [COLOR=rgb(26, 188, 156)][B]Current NATESTO® supply to the United States remains unaffected[/B][/COLOR] [B]TORONTO--(BUSINESS WIRE)-- [COLOR=rgb(184, 49, 47)][I]Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) today provided an update on the temporary unavailability of NATESTO® in Canada and South Korea, following the [U]previous announcement of the voluntary replacement of certain NATESTO® lots released[/U] on the Canadian and South Korean markets.[/I][/COLOR][/B] [COLOR=rgb(0, 0, 0)][B][I]Acerus made [U]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”)[/U]. 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,[U] [/U][/I][/B][/COLOR][COLOR=rgb(184, 49, 47)][I][B][U]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[/U]. In the event that Health Canada utilizes the full regulatory allotted time for reviewing a SNDS, [/B][/I][/COLOR][COLOR=rgb(41, 105, 176)][I][B]Acerus would expect the Revised Batch to be released in the Canadian Market in Q1-2021.[/B][/I][/COLOR][I] [B][U]Acerus continues to work with Health Canada to facilitate an expeditious review of the SNDS and minimize market disruptions[/U].[/B] [/I] [COLOR=rgb(26, 188, 156)][I][B]At this time, the current supply of NATESTO® to the United States is not affected by this situation[/B][/I][/COLOR][I]. [/I][COLOR=rgb(184, 49, 47)][B][I][U]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[/U][/I].[/B][/COLOR] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
TEMPORARY UNAVAILABILITY OF NATESTO® IN CANADA AND SOUTH KOREA
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