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Stock Market & Financial Investment News

News Breaks
August 22, 2014
16:11 EDTACTActavis confirms generic Neupro patent challenge
Actavis confirmed that it has filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to market Rotigotine Extended-release Transdermal Film, 1 mg/24 hr, 2mg/24 hr, 3 mg/24hr, 4 mg/24 hr, 6mg/24hr, and 8 mg/24 hr. Actavis' ANDA product is a generic version of UCB's Neupro, which is indicated for the treatment of signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome. UCB and LTS Lohmann Therapie-Systeme AG filed suit against Actavis' subsidiaries on August 21 in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain U.S. Patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Neupro and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending June 30, Neupro had total U.S. sales of approximately $85M, according to IMS Health data.
News For ACT From The Last 14 Days
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April 28, 2015
10:19 EDTACTPershing Square lists Herbalife, Actavis as top Q1 losers
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April 24, 2015
09:27 EDTACTActavis' Dalvance shows positive Phase 3 results for skin infections
Actavis announced positive top-line results for study DUR001-303, a phase 3 study comparing a single 1500 mg dose of Dalvance with the same total dose given as two-doses one week apart, for the treatment of acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus. Preliminary top-line data demonstrated the 1500 mg single-dose of Dalvance achieved its primary endpoint of non-inferiority to the two-dose regimen at 48-72 hours after initiation of therapy. Actavis plans to file a supplemental New Drug Application with these data in Q3.
07:09 EDTACTCipher Pharmaceuticals announces Markman hearing in Absorica patent suit
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April 23, 2015
08:16 EDTACTActavis launches Avycaz anti-infective in U.S.
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April 22, 2015
07:37 EDTACTOrexigen and Takeda receive Paragraph IV certification notice
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April 20, 2015
16:22 EDTACTActavis reports CCO Charles Mayr to retire for health reasons
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08:12 EDTACTActavis's BOTOX label approved by FDA for spasticity treatment
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07:18 EDTACTAmerican Academy of Neurology to hold annual meeting
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April 14, 2015
06:18 EDTACTActavis urges U.S. appeals court to reverse decision on Namenda, AP reports
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