PharmaTher Announces Update on FDA New Drug Application for Ketamine
PharmaTher Holdings announced receiving satisfactory preliminary FDA responses regarding their Ketamine product's Abbreviated New Drug Application. The company canceled the post-complete response letter meeting scheduled for December 2, 2024, as no further discussion was needed. Following the FDA's Complete Response Letter from October 22, 2024, which cited MINOR deficiencies, PharmaTher plans to submit a MINOR AMENDMENT by January 2025. The FDA's requests focus on drug substance, product, manufacturing, and microbiology updates, with no concerns about stability or need for new clinical studies.
PharmaTher Holdings ha annunciato di aver ricevuto risposte preliminari soddisfacenti dalla FDA riguardo alla loro domanda abbreviata di nuovo farmaco per il prodotto a base di Ketamina. L'azienda ha annullato l'incontro programmato per il 2 dicembre 2024, relativo alla lettera di risposta completa, in quanto non era necessaria ulteriore discussione. Dopo la lettera di risposta completa della FDA del 22 ottobre 2024, che ha evidenziato piccole carenze, PharmaTher prevede di presentare una modifica minore entro gennaio 2025. Le richieste della FDA si concentrano su aggiornamenti riguardanti il principio attivo, il prodotto, la produzione e la microbiologia, senza preoccupazioni relative alla stabilità o necessità di nuovi studi clinici.
PharmaTher Holdings anunció que recibió respuestas preliminares satisfactorias de la FDA con respecto a la Aplicación Abreviada de Nuevo Medicamento de su producto basado en Ketamina. La compañía canceló la reunión programada para el 2 de diciembre de 2024, relacionada con la carta de respuesta completa, ya que no se necesitaba más discusión. Tras la carta de respuesta completa de la FDA del 22 de octubre de 2024, que señalaba deficiencias menores, PharmaTher planea presentar una enmienda menor para enero de 2025. Las solicitudes de la FDA se centran en actualizaciones sobre la sustancia activa, el producto, la fabricación y la microbiología, sin preocupaciones sobre la estabilidad o la necesidad de nuevos estudios clínicos.
PharmaTher Holdings는 그들의 케타민 제품의 약물 신청에 대한 FDA의 만족스러운 초기 답변을 받았다고 발표했습니다. 회사는 2024년 12월 2일로 예정된 후속 완전 응답 서한 회의를 취소했습니다. 이는 추가 논의가 필요하지 않았기 때문입니다. 2024년 10월 22일에 발표된 FDA의 완전 응답 서한은 사소한 문제점들을 지적했으며, PharmaTher는 2025년 1월까지 소소한 수정안을 제출할 계획입니다. FDA의 요청은 약물 성분, 제품, 제조 및 미생물학 업데이트에 중점을 두고 있으며, 안정성에 대한 우려나 새로운 임상 연구의 필요성은 없습니다.
PharmaTher Holdings a annoncé avoir reçu des réponses préliminaires satisfaisantes de la FDA concernant la demande abrégée de nouveau médicament pour leur produit à base de Kétamine. L'entreprise a annulé la réunion prévue pour le 2 décembre 2024, qui était liée à la lettre de réponse complète, car aucune discussion supplémentaire n'était nécessaire. Suite à la lettre de réponse complète de la FDA du 22 octobre 2024, qui mentionnait des défauts mineurs, PharmaTher prévoit de soumettre un amendement mineur d'ici janvier 2025. Les demandes de la FDA se concentrent sur les mises à jour concernant la substance médicamenteuse, le produit, la fabrication et la microbiologie, sans préoccupations quant à la stabilité ou la nécessité de nouvelles études cliniques.
PharmaTher Holdings gab bekannt, dass sie positive vorläufige Antworten von der FDA zu ihrem Ketamin-Produkt im Rahmen des verkürzten Antrags auf Zulassung erhalten haben. Das Unternehmen hat das für den 2. Dezember 2024 geplante Treffen zur vollständigen Antwortbrief-Abstimmung abgesagt, da keine weiteren Gespräche notwendig waren. Nach dem vollständigen Antwortschreiben der FDA vom 22. Oktober 2024, das geringe Mängel aufwies, plant PharmaTher, bis Januar 2025 eine geringe Änderung einzureichen. Die Anforderungen der FDA konzentrieren sich auf Aktualisierungen der Wirkstoffsubstanz, des Produkts, der Herstellung und der Mikrobiologie, ohne Bedenken hinsichtlich der Stabilität oder der Notwendigkeit neuer klinischer Studien.
- FDA classified deficiencies as MINOR, indicating less significant concerns
- No new preclinical or clinical studies required by FDA
- Ketamine submission batches achieved 18 months stability without issues
- FDA responses were satisfactory requiring no further discussion
- FDA approval delayed due to Complete Response Letter requiring additional information
- Need for new and updated information related to drug substance, manufacturing, and microbiology
FDA provided preliminary responses to questions contained in the clarification only post-CRL meeting scheduled for December 2, 2024
PharmaTher has decided to cancel the meeting as the FDA preliminary responses were satisfactory and do not require further discussion
PharmaTher initiated activities to address the MINOR deficiencies cited in the CRL
TORONTO, Nov. 26, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA provided preliminary responses (the “Responses”) to questions contained in the post-complete response letter clarification meeting (the “Meeting”) scheduled for December 2, 2024. PharmaTher has decided to cancel the Meeting as the Responses were satisfactory and do not require further discussion. The Company expects to resubmit information to address the deficiencies classified as MINOR in the complete response letter (“CRL”) by January 2025.
Fabio Chianelli, Chairman and CEO of PharmaTher, commented: “We are very pleased with the responses by the FDA to the clarification questions in our post-CRL meeting request. The FDA has addressed our questions, paving the way for our Ketamine product’s new drug approval. As such, we decided to cancel the meeting, and our team has already begun compiling the responses. We have also initiated additional tests to address the MINOR deficiencies in the CRL, and we expect to submit the MINOR AMENDMENT by January 2025.”
As previously announced, the Company requested the Meeting in response to the FDA issuing a CRL, dated October 22, 2024, for the Company’s Ketamine product’s Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024.
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 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.
The Company will 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. Learn more at PharmaTher.com.
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
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