Valeant Pharmaceuticals Gets Boost From FDA Update

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Shares of Valeant Pharmaceuticals International Inc. (NYSE: VRX) saw a handy gain on Thursday after the company provided an update from the U.S. Food and Drug Administration (FDA). Specifically, the agency confirmed that it intends to issue a Voluntary Action Indicated (VAI) inspection classification for its Bausch + Lomb manufacturing facility in Florida.

This pharma giant has been under fire for over a year now, with shares practically falling off a cliff in that time. The stock looks like it has made a turnaround since mid-April, but still the numbers pale in comparison to last year. Any good news is especially welcome at this firm.

For some quick background: A VAI inspection classification occurs when objectionable concerns were observed by FDA inspectors at a facility, but the problems do not meet the threshold of regulatory significance.

Following the FDA confirmation and as further evidence of the progress made at the Tampa facility, Valeant received approval yesterday for a Supplemental New Drug Application (NDA) for the facility to be a release testing facility for the drug substance Alaway (ketotifen fumarate ophthalmic solution).

Joseph C. Papa, board chair and chief executive of Valeant, commented:

Following continued close collaboration with FDA inspectors, today, the FDA confirmed that all issues related to a Current Good Manufacturing Practice inspection at the Tampa facility are being satisfactorily resolved, and VAI status will soon be granted to the facility. We expect this to facilitate our current and upcoming regulatory submissions of products manufactured at the facility.

Excluding Thursday’s move, Valeant shares are down 2.6% year to date. Over the past 52 weeks, the stock is down a whopping 47%.

Shares of Valeant were last seen up about 3% at $14.61 on Thursday, with a 52-week range of $8.31 to $32.74.