Valeant gives six months timeline for FL plant reinspection after eye drug CRL
Last month, drugmaker Valeant announced it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the manufacture of its ophthalmic candidate latanoprostene bunod ophthalmic solution 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.
The letter came following an inspection in February at the Tampa, Florida facility, operated by Valeant’s Bausch + Lomb subsidiary.
During a call to discuss the firm’s Q2 2016 results this week, Valeant CEO Joseph Papa spoke about the CRL and said the firm has been working with the FDA to resolve the open issues.
“It was both a general inspection and a preapproval inspection in February of 2016, so both preapproval and a general inspection occurred, and it was during the preapproval side that they experienced some questions that they've raised,” he told stakeholders.
“We've been working very diligently since that February time to resolve those questions. As to the situation we find ourselves today with the CRL, we feel that the changes that will be required for re-inspection is something that we can get accomplished within the next six months and be ready for a re-inspection at that time.”
Papa added the CRL did not identify any efficacy or safety concerns for latanoprostene bunod, and the “inspection and the resulting observations have not disrupted any manufacturing or shipment from the Tampa site, and we do not expect any recalls of existing products.”
For the second quarter 2016, Valeant reported a y-o-y drop in revenues of 11% to $2.4bn and a net loss of $302m, compared to $53m in the same quarter 2015.
