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February 13, 2014
08:33 EDTTEVATeva announces FDA grants SYNRIBO full approval
Teva Pharmaceutical announced that the U.S. Food and Drug Administration has granted full approval of SYNRIBO for injection. This oncology portfolio product received an accelerated approval in October 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA. The company said, "With this approval, based on the final analysis of two Phase II trials that evaluated efficacy and tolerability data of SYNRIBO, we believe healthcare providers can be even more confident in the clinical profile of this important medicine."
News For TEVA From The Last 14 Days
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August 28, 2014
11:22 EDTTEVAMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
07:21 EDTTEVATeva recalls batch of generic Parkinson's drug in U.S., Globes reports
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August 21, 2014
15:16 EDTTEVADEA restricts painkiller drug prescriptions to curb abuse, WSJ reports
The Drug Enforcement Agency, or DEA, will reclassify hydrocodone combination painkiller drugs and place them in the category of medical substances that have the highest potential for harm in an attempt to curb the widespread abuse of the drugs, according to The Wall Street Journal. The rescheduling of the drugs will take effect in 45 days and result in people being able to obtain the drug for only 90 days without obtaining a new prescription. Major manufacturers of these drugs include Teva Pharmaceutical (TEVA), Mallinckrodt (MNK), AbbVie (ABBV), and Actavis (ACT). Reference Link
August 19, 2014
05:11 EDTTEVAGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
10:06 EDTTEVALannett surges after upbeat Q4, FY14 outlook
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08:50 EDTTEVATeva management to meet with JPMorgan
Meeting to be held in Boston on August 20 hosted by JPMorgan.

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