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FDA Refuses to Withdraw Zicam Recall
Posted by: Stephen Leshner
March 09, 2010
Topic: PRODUCT LIABILITY
PDATE 1-Matrixx: FDA declines to withdraw warning letter
Tue Mar 9, 2010 6:27am ESTStocks
Matrixx Initiatives MTXX.O $4.81 -0.06-1.23% 10:31am MST* Says FDA reaffirms original position
Stocks | Regulatory News | Healthcare
* Co says evaluating options
March 9 (Reuters) - Matrixx Initiatives Inc (MTXX.O) said U.S. health regulators declined to withdraw the warning letter on the company's nasal versions of Zicam cold remedy.
Last June, the company voluntarily withdrew two of its existing Zicam products after the U.S. Food and Drug Administration issued a warning letter that the products could cause a loss of smell. [ID:nN24151638]
In October, the company had said that the FDA had indicated that it was unwilling to reverse its position.
In a regulatory filing with the U.S. Securities and Exchange Commission Tuesday, the company said it had filed in November a response to the warning letter but the FDA reaffirmed its original position.
Matrixx said it was evaluating its options.
