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News Breaks
July 8, 2014
16:11 EDTACTActavis files ANDA for Dalfampridine tablets
Actavis confirmed that it has filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval to market Dalfampridine Extended-release Tablets, 10 mg. Actavis' ANDA product is a generic version of Acorda Therapeutics' Ampyra, which is indicated as a treatment to improve walking in patients with multiple sclerosis.
News For ACT From The Last 14 Days
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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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April 13, 2015
16:37 EDTACTActavis announces availability of 52mg Liletta to prevent pregnancy
Actavis and Medicines360, a nonprofit women's health pharmaceutical company, announced that Liletta 52 mg is now available in the U.S. for use by women to prevent pregnancy for up to three years.
10:52 EDTACTMeister says Actavis bought great companies, can continue growing
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09:27 EDTACTActavis and Medicine360 announce Liletta es available in the U.S.
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08:34 EDTACTZoetis names Actavis Executive Chairman Paul Bisaro to board
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