Adcoms y DVAX
Como prometí, aquí están los datos de las cancelaciones. La primera que aparece es la de DVAX, y la segunda la notificación más parecida. Con la tercera, que guarda también cierto parecido, tras la cancelación recibió una CRL. Mi conclusión es que tardarán unos meses en solventar los "outstanding issues" y el valor irá a la baja hasta que convoquen la nueva, si la convocan y no hay una CRL antes.
A continuación hago también un resumen de todas las frases aparecidas.
cancelled to allow time for the FDA to review and resolve several outstanding issues. The agency intends to continue evaluating and will schedule an Advisory Committee meeting in the future, as needed.
- Dynavax, 16 noviembre 2016
cancelled to allow time for the FDA to consider new information
-sugammadex sodium injection, by Organon USA, 18 marzo 2015
(anteriormente cancelado también sin más el 18 de julio de 2013).
Comité positivo 6 de noviembre 2015. “We believe that Bridion has the potential to offer anesthesia professionals an important new option to reverse neuromuscular blockade in the surgical setting,” said Dr. David Michelson, head of global clinical development for neuroscience, Merck Research Laboratories. “Today’s discussion is one step in the regulatory process, and we look forward to working with the FDA as it completes the review of our New Drug Application for Bridion.”
Se aprueba finalmente el 15 de diciembre de 2015
no longer needs to discuss the issues that were originally under consideration in the review of the application The Agency intends to continue evaluating NDA 200-436 and, as needed, may schedule an Advisory Committee meeting in the future.
new drug application
-(NDA) 200-436, by Repligen Corporation, 31 mayo 2012
El 22 de junio recibió una CRL:
additional clinical efficacy and safety trial data will be required to support potential approval of the NDA
because the issues for which the FDA was seeking the scientific input of the committee have been resolved:
- YERVOY (ipilimumab), submitted by Bristol-Myers Squibb Co 9 febrero 2011
- pomalidomide by Celgene 8 noviembre 2012
Advisory Committee Meeting cancelled: new drug application
- Oxymorphone HCl Extended-Release Tablets, Endo Pharmaceuticals, 2 diciembre 2010
- voclosporin by Lux Biosciences Incorporated, 28 de junio 2010
- EGRIFTA (tesamorelin acetate) sterile lyophilized powder for injection, by Theratechnologies, 24 febrero 2010
- CYMBALTA (duloxetine HCL) Capsules, by Eli Lilly and Company, 28 enero 2010
- Tykerb (lapatinib) by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline, 24 julio 2012
- MOXDUO by QRxPharma, 17 julio 2013
Advisory Committee Meeting cancelled: discuss biologics license application
- REPLAGAL (by Shire Human Genetics Therapies, 27 marzo 2012
advisory committee meeting is no longer needed. recommendations and vote on information regarding the premarket approval application (PMA)
- Organ Care System by TransMedics, 19 noviembre 2015
cancelled because the FDA has determined that outside, expert advice is no longer needed.
- new drug application (NDA) 207959, enclomiphene citrate by Repros Therapeutics, 2 nov 2015
Meeting is no longer needed. New drug application. the sNDA has been withdrawn.
- OXYCONTIN (by Purdue Pharmam 7-8 julio 2015
- imatinib mesylate by Novartis, 14 septiembre 2012
has been CANCELLED (sin más)
- PIXUVRI (pixantrone dimaleate), 9 febrero 2012
- sugammadex sodium injection, submitted by Organon USA Inc, 18 julio 2013
Dispute Resolution Panel. Cancellation of meeting (sin más)
- SEDASYS Computer-Assisted Personalized Sedation System; 14 diciembre 2011
Dispute Resolution Panel. To discuss denial of a premarket approval application
- Oxiplex®/SP Gel (OXIPLEX) submitted by FzioMed, Inc.--the sponsor for OXIPLEX, 10 junio 2014
«Después de nada, o después de todo/ supe que todo no era más que nada.»
