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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Natesto: large shards UPDATE- batch is all bad.
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<blockquote data-quote="madman" data-source="post: 277293" data-attributes="member: 13851"><p><strong>11/2019</strong></p><p>[URL unfurl="true"]https://www.excelmale.com/threads/temporary-unavailability-of-natesto%C2%AE-in-canada-and-south-korea.19880/[/URL]</p><p></p><p></p><p></p><p></p><p></p><p>[ATTACH=full]42259[/ATTACH]</p><p>[ATTACH=full]42260[/ATTACH]</p><p></p><p></p><p></p><p></p><p></p><p><strong>pg. 8-10</strong></p><p>[ATTACH=full]42261[/ATTACH]</p><p></p><p></p><p><em><strong>*On August 2, 2019, the Corporation announced that it had <u>identified four commercial lots of Natesto®</u>released in the Canadian and South Korean markets that were <u>found to be non-conforming during long term stability studies, even though such lots were fully in-specification at the time of release</u>.</strong> <strong>This post release <u>non-conformity is not harmful to the patient, but may result in difficulties in dispensing</u>.</strong> At that time, the temporary shortage of the product in the Canadian and South Korean markets was expected to continue until the end of October 2019. The Corporation noted this shortage on the Drug Shortages Canada website and continued to dialogue with Health Canada to identify solutions to try to minimize the disruption to patients in the affected markets.</em></p><p><em></em></p><p><em>*On November 1, 2019, the Corporation provided an update on the temporary unavailability of Natesto® in Canada and South Korea, <strong>following the previous announcement of the <u>voluntary recall of certain Natesto® lots</u> released on the Canadian and South Korean markets</strong></em></p><p><em><strong></strong></em></p><p><em><strong>*The Corporation initially made <u>minor modifications to the manufacturing process that appeared to have resolved the previously identified issues and has produced a batch of Natesto®</u> (<u>the “Revised Batch</u>”).<u>While Acerus believed the changes would have been classified by Health Canada as level III</u>, thereby requiring only an annual notification update to Health Canada and allowing for product to be released in Q4-2019, <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>.<u> Ultimately, the issue was resolved by the Corporation providing an internal corrective action plan in February 2021</u>. <u>The Corporation notified Health Canada of its intention to reactivate the DIN for Natesto® in July 2021</u>.</strong></em></p><p><em><strong></strong></em></p><p><em><strong>*On July 28, 2020, the Corporation announced that production of new batches of Natesto® (testosterone nasal gel) was underway and that shipments were already in transit to several key markets in North America and Asia (the United States, Taiwan and South Korea). </strong>The first country resupplied with Natesto® was the United States, ensuring that product is available to meet anticipated demand in support of the Acerus Specialty Sales Force. In addition, <strong>Eu HWA, a subsidiary of Orient EuroPharma (“OEP”) – The Corporation’s licensee across South Asia – officially introduced Natesto® to Taiwan at the Taiwanese Urology Association’s annual meeting on August 22-23, 2020 representing the second commercial launch of Natesto® outside North America.</strong> OEP is also preparing entry strategies for nearby markets including Hong Kong, the Philippines, Singapore, Malaysia & Vietnam. <strong>Supply of Natesto® in Canada is expected to resume in 2021.</strong></em></p><p><em><strong></strong></em></p><p><em><strong>*<em><strong>The C</strong>ompany also remains optimistic about a return of NATESTO® to Canada during 2021. <u>The first batch of NATESTO® for this market has already been manufactured and is undergoing stability studies</u>. <u>At the same time, Acerus has begun the regulatory work and commercial preparations required to support the reintroduction</u> of NATESTO® in Canada.</em></strong></em></p><p></p><p>[URL unfurl="true"]https://recalls-rappels.canada.ca/en/alert-recall/natesto-gel-2019-08-07[/URL]</p></blockquote><p></p>
[QUOTE="madman, post: 277293, member: 13851"] [B]11/2019[/B] [URL unfurl="true"]https://www.excelmale.com/threads/temporary-unavailability-of-natesto%C2%AE-in-canada-and-south-korea.19880/[/URL] [ATTACH type="full" alt="1710106526924.png"]42259[/ATTACH] [ATTACH type="full" alt="1710106619258.png"]42260[/ATTACH] [B]pg. 8-10[/B] [ATTACH type="full" alt="1710106661857.png"]42261[/ATTACH] [I][B]*On August 2, 2019, the Corporation announced that it had [U]identified four commercial lots of Natesto®[/U]released in the Canadian and South Korean markets that were [U]found to be non-conforming during long term stability studies, even though such lots were fully in-specification at the time of release[/U].[/B] [B]This post release [U]non-conformity is not harmful to the patient, but may result in difficulties in dispensing[/U].[/B] At that time, the temporary shortage of the product in the Canadian and South Korean markets was expected to continue until the end of October 2019. The Corporation noted this shortage on the Drug Shortages Canada website and continued to dialogue with Health Canada to identify solutions to try to minimize the disruption to patients in the affected markets. *On November 1, 2019, the Corporation provided an update on the temporary unavailability of Natesto® in Canada and South Korea, [B]following the previous announcement of the [U]voluntary recall of certain Natesto® lots[/U] released on the Canadian and South Korean markets *The Corporation initially made [U]minor modifications to the manufacturing process that appeared to have resolved the previously identified issues and has produced a batch of Natesto®[/U] ([U]the “Revised Batch[/U]”).[U]While Acerus believed the changes would have been classified by Health Canada as level III[/U], thereby requiring only an annual notification update to Health Canada and allowing for product to be released in Q4-2019, [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].[U] Ultimately, the issue was resolved by the Corporation providing an internal corrective action plan in February 2021[/U]. [U]The Corporation notified Health Canada of its intention to reactivate the DIN for Natesto® in July 2021[/U]. *On July 28, 2020, the Corporation announced that production of new batches of Natesto® (testosterone nasal gel) was underway and that shipments were already in transit to several key markets in North America and Asia (the United States, Taiwan and South Korea). [/B]The first country resupplied with Natesto® was the United States, ensuring that product is available to meet anticipated demand in support of the Acerus Specialty Sales Force. In addition, [B]Eu HWA, a subsidiary of Orient EuroPharma (“OEP”) – The Corporation’s licensee across South Asia – officially introduced Natesto® to Taiwan at the Taiwanese Urology Association’s annual meeting on August 22-23, 2020 representing the second commercial launch of Natesto® outside North America.[/B] OEP is also preparing entry strategies for nearby markets including Hong Kong, the Philippines, Singapore, Malaysia & Vietnam. [B]Supply of Natesto® in Canada is expected to resume in 2021. *[I][B]The C[/B]ompany also remains optimistic about a return of NATESTO® to Canada during 2021. [U]The first batch of NATESTO® for this market has already been manufactured and is undergoing stability studies[/U]. [U]At the same time, Acerus has begun the regulatory work and commercial preparations required to support the reintroduction[/U] of NATESTO® in Canada.[/I][/B][/I] [URL unfurl="true"]https://recalls-rappels.canada.ca/en/alert-recall/natesto-gel-2019-08-07[/URL] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Natesto: large shards UPDATE- batch is all bad.
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