K-V resumes limited manufacturing

K-V Pharmaceutical Company, which has encountered regulatory and legal difficulties over the past few years, has received permission from the US Food and Drug Administration (FDA) to resume production of its potassium chloride products following a successful inspection of the company's manufacturing facilities.

K-V recalled all of the products it manufactures early last year after FDA inspections turned up manufacturing problems including oversized tablets that could result in overdoses. The company also halted manufacturing and shipping of further products at that time.

The speciality pharma firm's consent decree with the FDA makes resumption of manufacturing and shipment of the products contingent on successful inspections.

The results of an inspection conducted in mid-August have allowed the company to begin producing the potassium chloride products Micro-K 10mEq and Micro-K 8mEq, which are indicated for the prevention and treatment of hypokalaemia, a condition characterised by low serum potassium that can lead to cardiovascular complications and impaired muscle function.

K-V said it intends to begin shipping the potassium chloride products next week, and that the FDA is expected to conduct additional inspections to decide whether other products may also be returned to the marketplace in the near future.

K-V markets its products through Ther-Rx Corporation, its branded drug subsidiary. Its portfolio includes the estrogen therapy Evamist (estradiol transdermal spray), which is intended to treat hot flashes, and the anti-infectives Clindesse and Gynazole-1, which treat bacterial vaginosis and yeast infections.

The company's generic drug subsidiary Ethex ceased operations earlier this year after pleading guilty to criminal charges brought by the US Department of Justice over its failure to notify authorities about potentially dangerous manufacturing problems.