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News Breaks | | | | March 5, 2013 | | 08:39 EDT |  | IPXL | Impax warning letter resolution likely to take at least a year, says Wells Fargo
After the FDA re-inspected Impax's Hayward facility and found problems with the plant, Wells Fargo doesn't expect the issues to be resolved for at least another year. The firm doesn't expect the company's generic versions of gConcerta and Rytary to be approved this year, and it maintains a Market Perform rating. | |
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News For IPXL From The Last 14 Days Check below for free stories on IPXL the last two weeks. |
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| May 17, 2013 | | 08:41 EDT |  | IPXL | Impax commenced shipment of authorized generic Zomig
Impax (IPXL) announced that its generics division, Global Pharmaceuticals, commenced shipment of authorized generic Zomig tablets, as part of an agreement with AstraZeneca (AZN). Zomig is indicated for the treatment of migraine headaches in adults. According to IMS Health data, U.S. sales of Zomig tablets and orally disintegrating tablets were approximately $196M in the 12 months ended April 2013. | | | May 13, 2013 | | 07:49 EDT | | IPXL | FDA decision on Opana a modest positive for Impax, says Leerink
Leerink views the FDA's denial of Endo's (ENDP) Citizen Petition as a modest positive for Impax (IPXL), which it notes is the sole holder of 180 day exclusivity on generic Opana. However, Leerink says upside for Impax will be limited as Actavis (ACT), Sandoz, and Teva (TEVA) have settlements to enter the market starting in June 2013 when Impax's 180-day generic exclusivity expires. | |
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