KV Pharmaceutical is to return its first product to the market following a successful inspection of its facilities by the FDA.
In January 2009 KV voluntarily suspended manufacturing operations after recalling products the previous year. To resume shipping of its products KV is working to fulfil the terms of a consent decree it entered into with the US Food and Drug Administration (FDA).
Part of this process has now been completed. The FDA inspected KV’s quality systems, manufacturing processes and facilities during the week of August 16.
Successful completion of this inspection permits KV to reintroduce to market the first product, potassium chloride, approved under the consent decree. KV plans to begin shipping two forms of Micro-K (potassium chloride extended-release) this week.
Resumption of shipping is “a significant milestone” in the management team’s efforts to restore business at KV, said Greg Divis, president of Ther-Rx and interim president and CEO of KV.
“The successful FDA inspection of our facilities and approval of our return to market demonstrates our hard work and commitment to meeting and sustaining current good manufacturing practices (cGMP) requirements”, said Divis.
Additional FDA inspections of KV’s operations are now expected to occur to determine if the company is allowed to resume production and shipping of other products.
The markets responded favourably to the development sending KV’s share price up 18 per cent to close on Friday at $2.94. At its historical high in October 2007 KV’s share price was $31.02.