KV Pharmaceutical Co got U.S. regulatory approval
to reintroduce its first product that was pulled out of market due to
manufacturing problems, and expects to begin shipments next week, sending its
shares up as much as 92 percent.
The troubled drug maker, which was earlier sued by the U.S. Department of Justice, faced the U.S. Food and Drug Administration investigations for violating manufacturing guidelines and was stopped from making and shipping any of its drugs.
The company, a maker of women's healthcare products, pharmaceutical ingredients and generic drugs, received approval to market two doses of its potassium chloride product, named Micro-K, that is used to treat hypokalemia or low blood potassium.
The FDA is expected to conduct additional inspections with respect to the company's other products before deciding whether they can be manufactured and marketed.
The troubled drug maker, which was earlier sued by the U.S. Department of Justice, faced the U.S. Food and Drug Administration investigations for violating manufacturing guidelines and was stopped from making and shipping any of its drugs.
The company, a maker of women's healthcare products, pharmaceutical ingredients and generic drugs, received approval to market two doses of its potassium chloride product, named Micro-K, that is used to treat hypokalemia or low blood potassium.
The FDA is expected to conduct additional inspections with respect to the company's other products before deciding whether they can be manufactured and marketed.
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