Expectorant seizure easy to swallow for KV
The products, which are sold by KV's Ethex subsidiary, were seized as part of the Food and Drug Administration's (FDA) clampdown on unapproved uses of the muscle relaxant, which is employed as an expectorant in prescription and over-the-counter (OTC) cough remedies.
Earlier this year, an inspection of several of St-Louis-based KV's manufacturing facilities revealed that the firm had continued to manufacture TR products containing guaifenesin after the August 27, 2007 deadline issued by the FDA.
The seizure came as a result of a civil suit filed by US attorney Catherine Hanaway who commented that: "American consumers are entitled to have safe and effective drugs." Products impounded by the FDA include: PhenaVent capsules; Ethezyme Papain-Urea ointment; Hista-Vent DA tablets and Pseudovent capsules.
In response, KV said that the FDA had taken the action to control the disposal of the remaining inventories of the affected products. The firm added that it will "continue its cooperation with the FDA in bringing this matter to a final resolution."
KV also said that it has already written off the value of the affected products in filings submitted to the Securities and Exchange Commission (SEC) last month and "therefore, there will be no further financial impact."Nevertheless, yesterday's seizure coupled with Ethex' voluntary recall of a batch of morphine sulphate tablets in June, mark what has been a difficult few months for KV's manufacturing operations.
Regulatory status
Although guaifenesin has been approved by the FDA since the early 1950s, many recently developed timed-release (TR) cough medicines that contain the agent are sold without having gained the requisite regulatory clearance.
The agency explained that because the manufacturing processes used to make such products have not been scrutinized properly there is the potential that the drugs will release their active ingredients at an inappropriate rate and that this could pose a risk to patient health.
Commenting on the FDA KV seizure, Deborah Autor, director of the FDA's office of compliance in the Center for Drug Evaluation and Research, said that the agency will "take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date."
