The Food and Drug Administration (FDA) has started an inspection of the facility in Davie, Florida that, under its previous owner, was assigned Official Action Indicated (OAI) status in September 2005.
This put on hold any pending abbreviated new drug applications (ANDAs) for generic drugs manufactured at the facility.
The freeze on approvals has since applied to ANDAs filed by Watson for product candidates due to be manufactured in Florida.
After completing an inspection of the Davie facility in May 2005, the FDA issued a Form 483 listing deviations from current Good Manufacturing Practices (cGMPs) at the site.
At the time, Andrx said it had provided the agency with a detailed response to the Form 483, including a proposed corrective action plan, and was working to resolve the undisclosed problems as quickly as possible.
Nonetheless, the OAI status and the hold on ANDA approvals remained in place.
According to Watson, the last FDA inspection of the Davie facility resulted in nine Form 483 Inspectional Obervations citing " documentation, training, and other matters ".
Spokesperson Patty Eisenhaur said the agency had not indicated why it had taken so long to start re-inspecting the facility and that Watson had been hoping for a return visit within a year of the Andrx acquisition.
The Davie site is one of Watson's key US solid-dosage facilities, with capability to manufacture sustained-release formulations and high-potency compounds, Eisenhaur noted.
The company has not quantified the impact of the hold on ANDA approvals, which includes "missed revenue opportunity and also cost of goods as the facility isn't running at capacity ".
Nor is Watson disclosing the number of ANDAs currently in limbo because of the OIA, which affects only pipeline products and not the manufacture of drugs that have already been approved for production at the Davie site.
Among the key products awaiting approval and manufacturing clearance at Davie are generic versions of the ulcer treatment Prilosec (omeprazole) 40mg, of Concerta (methylphenidate HCl) for attention deficit hyperactivity disorder, and of the antihypertensives Cardizem LA (extended-release diltiazem) and Toprol XL (extended-release metoprolol succinate).
Also on hold is an approval application for Watson's branded antidiabetic, Actos (pioglitazone hydrochloride) plus MET (metformin) XR.
At the moment, Eisenhaur said, it was " too soon to tell how long FDA will be at the [Davie] site and how long it will take to resolve OIA status ".
Some indication of whether Watson expects to book any sales from the pending ANDAs this year may be available on 20 February, when the company provides its 2008 outlook as part of its year-end earnings call.
" While a resolution to the OAI status may enable product candidates to be approved, it does not ensure that any such ANDAs will be approved or, if approved, will be launched, " Watson cautioned.