Impax extended FDA review a marginal negative, says Wells Fargo Wells Fargo views the FDA's extension of the review period for Impax's Rytary as marginally negative since the data was an expected near-term catalyst for shares. However, Wells notes the FDA did not request any new clinical trials and that the delay provides more time for Impax to resolve the warning letter is previously received. Wells keeps a Market Perform rating on Impax.
News For IPXL From The Last 14 Days
Check below for free stories on IPXL the last two weeks.
Impax announces FDA performs inspection on Taiwan facility Impax announced that the FDA performed a general GMP inspection and a Pre-Approval Inspection for RYTARYTM at the company's Taiwan manufacturing facility from July 21 to July 26. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States. The FDA did not provide any status or classification to these observations and will wait until they have received and reviewed the company's response to provide this information. The Ccmpany has also not been informed by the FDA of the impact this Form 483 may have on RYTARY's October 9 review date under the Prescription Drug User Fee Act.