AstraZeneca International - pharmaceutical company, prescription drugs, medicine manufacturers

These press releases are for business and financial media.

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- 20 May 2009
- Court Grants AstraZeneca Preliminary Injunction Against Apotex in Pulmicort Respules Patent Litigation On 20 May 2009, the US District Court for the District of New Jersey granted AstraZeneca’s request for an injunction barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca’s PULMICORT RESPULES (budesonide inhalation suspension) in the US. No trial date for the patent litigation has been set.
- 11 May 2009
- AstraZeneca Announces Top Line Results From Pivotal Phase III Study for BRILINTA AstraZeneca today announced top line results from the phase III trial, PLATO, which demonstrate that BRILINTA, the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus clopidogrel, in the prevention of cardiovascular (CV) events in patients with ACS.
- 30 April 2009
- AstraZeneca PLC First Quarter Results 2009 AstraZeneca has proved to be resilient in the first quarter of 2009, the result of excellent execution in driving growth in key product franchises and in all regions, whilst delivering improvements in operating efficiency.
- 23 April 2009
- IRESSA (Gefitinib) Recommended for Approval for the Treatment of Non-Small Cell Lung Cancer in Europe AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), has issued a positive opinion supporting approval of the targeted oral anti-cancer drug, IRESSA (gefitinib).
- 23 April 2009
- US Food and Drug Administration Extends Review Timeline for Onglyza (Saxagliptin) New Drug Application AstraZeneca and Bristol-Myers Squibb reported today that the US Food and Drug Administration (FDA) has determined it needs additional time to complete the review of the New Drug Application (NDA) for ONGLYZA (saxagliptin) for the treatment of type 2 diabetes.
- 17 April 2009
- Court Grants AstraZeneca Temporary Restraining Order Against Apotex in Pulmicort Respules Patent Litigation On 16 April 2009, the US District Court for the District of New Jersey granted AstraZeneca’s request for a temporary restraining order, barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca’s PULMICORT RESPULES until further order of the court.
- 09 April 2009
- FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications On 8 April 2009, the U.S. Food and Drug Administration Psychopharmacologic Drugs Advisory Committee conducted a review of the safety and efficacy of supplemental new drug applications for SEROQUEL XR extended-release tablets proposed for the treatment of major depressive disorder and generalised anxiety disorder.
- 07 April 2009
- AstraZeneca Files Suit Against Apotex for a Declaratory Judgment of Infringement Against Pulmicort Respules Patents AstraZeneca has filed a lawsuit in the US District Court for the District of New Jersey against Apotex seeking a declaration of patent infringement.
- 06 April 2009
- AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old AstraZeneca today announced the company has received a Complete Response Letter from the US Food and Drug Administration for SYMBICORT pressurized metered dose inhaler for the long-term maintenance treatment of asthma in pediatric patients ages 6-11 years.
- 06 April 2009
- Sale of AstraZeneca OTC Product Portfolio Cleared by Swedish Competition Authority AstraZeneca today announced that the Competition Authority in Sweden has approved the divestment to GlaxoSmithKline of a portfolio of over-the-counter (OTC) products.