Thursday 13 March, 2008

Pharma news in brief

Barr receive FDA approval for Paclitaxel injection
Barr Pharma announced that its subsidiary, Plivia has received final approval from the USFDA for its generic version of Bristol-Myers Squibb Company's Taxol(R) (Paclitaxel) Injection USP, 6mg/mL, packaged in 100mg/16.7 mL and 300mg/50 mL Multiple-dose Vials. The Company plans to launch its product shortly.
Trail Date set for Quetiapine litigation
AstraZeneca announced a trial date has been set for patent litigation in the US District Court for the District of New Jersey against Teva Pharma. and Sandoz alleging infringement of AstraZeneca’s patent as a result of Teva’s and Sandoz’s filings of Abbreviated New Drug Applications (ANDAs). The ANDAs seek approval to market generic versions of Seroquel® (quetiapine fumarate tablets) in the US before Seroquel’s patent expires in 2011. The Court has set a date for trial beginning on 11 August 2008.
Connecticut AG Blumenthal Sue Eli Lilly For Illegal Marketing of Olanzapine for unapproved Uses
Attorney General Richard Blumenthal sued Eli Lilly for illegally marketing its antipsychotic drug Zyprexa (Olanzapine) for unapproved uses, and concealing the drug's serious side effects, for more than a decade. Eli Lilly allegedly corrupted physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children. The deceptive marketing campaign dangerously concealed risks associated with Zyprexa, including diabetes, cardiovascular problems, and significant weight gain. In a lawsuit filed today, Blumenthal seeks to recover millions of taxpayer and consumer dollars improperly spent on Zyprexa as a result of its illegal marketing, and millions more spent for treatment of serious side effects from Zyprexa. "The illegal marketing campaign exploited children and senior citizens - causing severe weight gain, diabetes and cardiovascular problems," Blumenthal said. "This scheme involved payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies. The drug was marketed for anxiety, depression and Attention Deficit Disorder in children when it was never approved for any use in children and caused serious side effects. "Through a complex series of illegal rackets and lies, Eli Lilly built a multi-billion dollar drug enterprise at the expense of taxpayers, consumers and patient lives. Today's action seeks millions for Connecticut taxpayers and consumers who continue to suffer the financial and physical ruin resulting from the improper prescribing of Zyprexa. "Eli Lilly adopted a sick marketing mindset: profits over patients, sales over safety. Driven by fierce greed, Eli Lilly corrupted doctors, pharmacies and public officials nationwide who easily abandoned integrity and decency for self-enrichment. My office will fight aggressively on behalf of Connecticut citizens who continue to pay the price of Eli Lilly's illegal, senseless schemes." Blumenthal sued pursuant to the Connecticut Unfair Trade Practices Act (CUTPA) and the federal Racketeering Influenced and Corrupt Organizations Act (RICO) on behalf of Department of Consumer Protection (DCP) Commissioner Jerry Farrell, Jr. and Department of Social Services (DSS) Commissioner Michael Starkowski.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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