Valeant nearing resolution of CRL, Papa says
- Even as Valeant continues its efforts to remake its image under new management, old (and new) problems continue to resurface. Among the many is a complete response letter Valeant received from the FDA in late July for violations at its Tampa, FL manufacturing site.
- The company gave an update on the CRL during its recent second quarter earnings call, reassuring investors a resolution is in sight.
- The CRL was originally received on July 21 after a February inspection found deficiencies tied to its manufacturing process for production of the eye drug Vesneo (latanoprostene bunod ophthalmic solution, 0.024%).
Valeant CEO Joseph Papa did his best to reassure investors the CRL is nearing a resolution.
"We've been working with the FDA to resolve the open issues, and we hope to complete activity required for an FDA reinspection within six months," he said.
"Importantly, the CRL did not identify any efficacy or safety concerns for latanoprostene bunod. Additionally, I wanted to be clear that this 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," added Papa.
Papa noted the inspection which led to the CRL was both a general inspection of the facility, as well as a pre-approval inspection.
While (relatively) minor, the CRL still set back Valeant's timeline for the drug. Up until late 2014, Valeant was prediciting peak global revenues topping $1 billion. If Valeant still hopes to match those lofty expectations, a quick resolution of the CRL as Papa outlined will be needed.
Valeant restructured its organization recently, opting to segment the business into three units instead of dividing up the company geographically. Papa emphasized during the earnings call that the Bausch & Lomb business would be the largest segment.
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