KV Pharma Says it Reached Manufacturing Agreement

Tue, 03/03/2009 - 5:41am
ST. LOUIS (AP) — KV Pharmaceutical Co., a drugmaker that suspended its manufacturing and shipping operations and has recalled products four times since last fall, said Monday it has reached an agreement with regulators that would allow it to resume those operations if it passes inspections. KV said it agreed to have an independent third party review its manufacturing facilities to certify they meet industry standards, which are called current good manufacturing practices. After that review, the Food and Drug Administration will determine if the facilities are compliant. The FDA will treat some products, including prenatal vitamins and hematinic products — or drugs designed to elevate levels of oxygen-carrying hemoglobin in the blood — as if they were new drug candidates. KV will be allowed to resume distribution of some of those products, which were the subject of a recall in early February, unless the FDA approves new drug applications for the products. The news sent KV shares up 41 cents, or 60.3 percent, to $1.09 in afternoon trading. After manufacturing resumes, KV will be required to submit to additional independent inspections at least every six months for the next two years, and annual inspections for the following three years, according to the U.S. Department of Justice. If KV does not comply with the agreement, termed a consent decree, or with good manufacturing practices or FDA guidelines, the FDA can order the company to cease operations, recall products, pay damages or take other corrective steps. KV recalled most of its products and ceased manufacturing and shipping in late January because the company could not certify the drugs were made under acceptable conditions. The company recalled other drugs in November and December because some tablets were accidentally oversized, which could have delivered larger-than-intended doses.

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