ANNO PROSSIMO STARAI DI NUOVO QUI A SBATTERE LA TESTA QUESTO E' UN TITOLO PORTASFIGA TOTALE.
July 22, 2016
No Safety or Efficacy Concerns or Additional Clinical Trials Identified for Approval of Latanoprostene Bunod
FDA Letter Related to CGMP at Bausch + Lomb Facility
LAVAL, Quebec, July 22, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA. The FDA's letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.
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August 07, 2017
LAVAL, Quebec, Aug. 7, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.
The CRL from the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant will work closely with the FDA to determine the appropriate next steps for the NDA.
Non c'è che dire: siamo proprio sfortunati. Siamo incappati in soci che non rispettano le regole e ne stiamo pagando care le conseguenze.
July 22, 2016
No Safety or Efficacy Concerns or Additional Clinical Trials Identified for Approval of Latanoprostene Bunod
FDA Letter Related to CGMP at Bausch + Lomb Facility
LAVAL, Quebec, July 22, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA. The FDA's letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.
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August 07, 2017
LAVAL, Quebec, Aug. 7, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.
The CRL from the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Fla. The FDA did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant will work closely with the FDA to determine the appropriate next steps for the NDA.