Matrixx must refile Zicam application; stock plummets 70 percent - Triangle Business Journal:

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The news sent sharese plummeting nearly 70 percentor $13.4t cents per share to close at $5.77 Tuesday. Matrixx must file a new applicatiob with the FDA for its Zicam Cold Remedy Nasal Gel and Zicam Cold RemedytGel Swab. The FDA said thosr products must contain warnings of the risk of possible which is lossof smell, said Siobhan DeLancey, spokeswoman for the FDA. “Thety are to stop marketing the products,” she “They have to provide us with a plan forinventory that’s already out there. If they want to continue marketinghthis product, they need to bring us a new drug applicatio n with studies and data to provde safety and efficacy.
” Matrixx officials did not return telephone but in an announcement said: “The companyy believes the FDA action is unwarranted and is in the proces of determining its response, whichb may include removing these productse from the marketplace,” the statement said. “These productsd constituted approximately 40 percent ofthe company’ s net sales in 2009.” DeLancey said the FDA does not have the authorituy to tell companies to recall their products. “Alk recalls are voluntary by the company,” she said. we tell the company we have a concern and they usuallhy work with us and do avoluntary recall.
” Matrixx’zs stock (Nasdaq:MTXX) closed at $5.78 on June 16. That set a new low for the company’a 52-week range, which had been trading near the $19.74 For the fiscal year endedsMarch 31, Matrixx reported $13.8 millionb in net income on $112 million in net up from $10.4 million in net incomee on $101 million in net sales a year ago.