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|July 08, 2015 1:48 p.m.|
|Teva First to Receive Approval and Launch Generic Axert® Tablets in the United States|
JERUSALEM--(BUSINESS WIRE)--Jul. 8, 2015--
The ANDA for almotriptan malate tablets submitted by Teva to the
Teva continues to deliver on its generics business strategy and remains focused on increasing its first to file regulatory submissions in
Axert® (almotriptan malate) tablets, marketed by
For more information about almotriptan malate tablets, please see accompanying Full Prescribing Information.
Paragraph IV certification
Paragraph IV certification provides opportunities for generic manufacturers to launch the generic version of a brand drug before the expiration of the brand drug’s patents are listed in the orange book, which requires generics manufacturers to certify that patents in the orange book are invalid, unenforceable, and/or the generic drug seeking to be approved will not infringe such patents.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially Copaxone® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.