Regulators says new medication doesn’t raise safety concern despite manufacturing scrutiny
The U.S. Food and Drug Administration hasn’t identified any safety concerns with a glaucoma medication from Valeant Pharmaceuticals, according to a news release.
The drug, latanoprostene bunod ophthalmic solution, 0.024%, is an eye drop for lowering intraocular pressure in patients with open angle glaucoma or ocular hypertension. The FDA had raised concerns related to a Current Good Manufacturing Practice (CGMP) inspection at a Bausch + Lomb manufacturing facility where the drug was manufactured, according to the news release.
Valeant has received a Complete Response Letter (CRL) from the agency regarding its New Drug Application (NDA) for the medication. The FDA’s letter “did not identify any 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%,” according to the release.
Valeant said it intended to meet with the FDA to work on a resolution to concerns raised in the inspection of the Bausch + Lomb facility.
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The drug, latanoprostene bunod ophthalmic solution, 0.024%, is an eye drop for lowering intraocular pressure in patients with open angle glaucoma or ocular hypertension. The FDA had raised concerns related to a Current Good Manufacturing Practice (CGMP) inspection at a Bausch + Lomb manufacturing facility where the drug was manufactured, according to the news release.
Valeant has received a Complete Response Letter (CRL) from the agency regarding its New Drug Application (NDA) for the medication. The FDA’s letter “did not identify any 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%,” according to the release.
Valeant said it intended to meet with the FDA to work on a resolution to concerns raised in the inspection of the Bausch + Lomb facility.
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