Andrx under scrutiny as FDA finds production problems
drugs manufacturer to fall foul of the US Food and Drug
Administration (FDA) because of quality issues at a manufacturing
plant.
Andrx has had a hold placed on the approval all of its new marketing applications after a routine FDA inspection in May uncovered problems at its facility in Davie, Florida.
Shares in the company plummeted 17 per cent to $3.50 on the news, as investors reacted to the news with trepidation, no doubt mindful of the fate of Able Laboratories which was forced to recall all its products, halt manufacturing and ultimately sell off kits assets after serious sterility issues were found at its production unit.
Andrx has already provided the FDA with a detailed response to the plant's failings, but the agency has not yet commented on this plan. It could seek various sanctions against Andrx for violations of current Good Manufacturing Practices (cGMP), or other applicable statutes and regulations.
The range of possible sanctions includes product recalls or seizures, fines, total or partial suspension of production and/or distribution, suspension of the FDA's review of product applications, enforcement actions, injunctions and civil or criminal prosecution. Under some circumstances, the FDA also has the authority to revoke previously granted drug approvals.
"Andrx is working to resolve the GMP issues at its facility as quickly as possible," the company said in a press release. "The timing of that resolution is uncertain, and is not solely in our control."
The production problems come at a bad time for Andrx, which saw revenues shrink by 11 per cent to $260m in the second quarter of this year as it felt the effects of increased competition in the generics market. Andrx has been trying to move into value-added products, applying controlled-release and other formulation technologies to its products, in order to protect its position in the marketplace.
