PharmaTher Announces Update on FDA New Drug Application for Ketamine
PharmaTher Holdings announced that the FDA has granted a post-complete letter clarification meeting scheduled for December 2, 2024, following a Complete Response Letter (CRL) issued on October 22, 2024, for their ketamine Abbreviated New Drug Application. The deficiencies cited in the CRL are classified as MINOR, requiring new and updated information related to drug substance, product, manufacturing, and microbiology. The FDA expressed no concerns about ketamine submission batch stability and requested no new preclinical or clinical studies. The resubmission will be considered a MINOR AMENDMENT.
PharmaTher Holdings ha annunciato che la FDA ha concesso un incontro di chiarimento dopo il completamento della lettera, programmato per il 2 dicembre 2024, a seguito di una Complete Response Letter (CRL) emessa il 22 ottobre 2024, per la loro Abbreviated New Drug Application (ANDA) relativa alla ketamina. Le carenze citate nella CRL sono classificate come MINORI, richiedendo informazioni nuove e aggiornate relative alla sostanza medicinale, al prodotto, alla produzione e alla microbiologia. La FDA non ha espresso preoccupazioni riguardo alla stabilità del lotto di presentazione della ketamina e non ha richiesto nuovi studi preclinici o clinici. La re-invio sarà considerata un EMENDAMENTO MINORE.
PharmaTher Holdings anunció que la FDA ha concedido una reunión de aclaración posterior a la carta completa, programada para el 2 de diciembre de 2024, tras una Complete Response Letter (CRL) emitida el 22 de octubre de 2024, para su solicitud de nuevo fármaco abreviada relacionada con la ketamina. Las deficiencias citadas en la CRL se clasifican como MENORES, requiriendo información nueva y actualizada relacionada con la sustancia activa, el producto, la fabricación y la microbiología. La FDA no expresó preocupaciones sobre la estabilidad del lote de presentación de la ketamina y no solicitó nuevos estudios preclínicos o clínicos. La reenvío se considerará una ENMIENDA MENOR.
PharmaTher Holdings는 FDA가 2024년 12월 2일로 예정된 후속 설명 회의를 승인했다고 발표했습니다. 이는 2024년 10월 22일에 발행된 Complete Response Letter (CRL)와 관련이 있으며, 그들은 케타민 약물에 대한 약식 신약 신청과 관련하여 발행되었습니다. CRL에서 언급된 결함은 경미한 것으로 분류됩니다, 약물 성분, 제품, 제조 및 미생물학에 대한 새로운 정보와 업데이트가 필요합니다. FDA는 케타민 제출 배치의 안정성에 대해 우려하지 않았으며 새로운 전임상 또는 임상 연구를 요청하지 않았습니다. 재제출은 경미한 수정안으로 간주될 것입니다.
PharmaTher Holdings a annoncé que la FDA a accordé une réunion de clarification post-complete, prévue pour le 2 décembre 2024, suite à une Complete Response Letter (CRL) émise le 22 octobre 2024, concernant leur demande d'autorisation de mise sur le marché d'un nouveau médicament abrégé pour la kétamine. Les déficiences citées dans la CRL sont classées comme mineures, nécessitant des informations nouvelles et mises à jour relatives à la substance médicamenteuse, au produit, à la fabrication et à la microbiologie. La FDA n'a exprimé aucune préoccupation concernant la stabilité du lot soumis pour la kétamine et n'a pas demandé de nouvelles études précliniques ou cliniques. La réintroduction sera considérée comme un AMENDEMENT MINEUR.
PharmaTher Holdings hat angekündigt, dass die FDA ein Nachbesprechungstreffen, das für den 2. Dezember 2024 angesetzt ist, genehmigt hat, nachdem am 22. Oktober 2024 ein Complete Response Letter (CRL) für ihren ketaminbezogenen Abbreviated New Drug Application (ANDA) ausgestellt wurde. Die im CRL angeführten Mängel werden als MINOR eingestuft, was neue und aktualisierte Informationen über den Arzneistoff, das Produkt, die Herstellung und die Mikrobiologie erfordert. Die FDA äußerte keine Bedenken hinsichtlich der Stabilität des ketaminbezogenen Einreichungsbatches und forderte keine neuen präklinischen oder klinischen Studien an. Die erneute Einreichung wird als MINORE ÄNDERUNG betrachtet.
- FDA classified deficiencies as MINOR, indicating less severe concerns
- No new preclinical or clinical studies required by FDA
- Ketamine submission batches achieved 18 months stability without issues
- Resubmission classified as MINOR AMENDMENT, suggesting faster review process
- FDA approval delayed due to Complete Response Letter
- Additional information required for drug substance, product, manufacturing, and microbiology
FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024
Company initiated activities to address the deficiencies cited in the CRL
TORONTO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA granted a post-complete letter clarification meeting (the “Meeting”) scheduled for December 2, 2024.
As previously announced, the Company requested the Meeting in response to the FDA issuing a complete response letter (“CRL”), dated October 22, 2024, for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024.
The Company has initiated activities to address the deficiencies cited in the CRL. The deficiencies cited in the CRL are classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested. As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR.
The Company will announce a proposed timeline for the resubmission to this CRL after the Meeting and continue to provide updates as they occur.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, mental health, neurological, and medical countermeasures indications. PharmaTher owns
For more information about PharmaTher, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
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FAQ
What were the FDA's concerns in PharmaTher's (PHRRF) ketamine application CRL?
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