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In a ruling that could change the way the FDA grants 180-day exclusivity, a federal judge has reversed the agency’s decision that Apotex must share its six-month exclusivity period for a version of GlaxoSmithKline’s depression drug Paxil with rival generic firms.
Generic firm Apotex has dropped its antitrust lawsuit against Allergan that alleges the eye care drugmaker improperly obtained a patent to prevent generic competition for its anti-inflammatory eye drug Acular.
In a decision that overturns FDA policy, a federal judge has ruled that generic firm Apotex does not have to share its 180-day exclusivity period for a version of GlaxoSmithKline’s depression drug Paxil (paroxetine HCl) with rival firms.
The Internal Revenue Service (IRS) says GlaxoSmithKline (GSK) owes an additional $2.7 billion in taxes stemming from revenues GSK predecessor Glaxo Wellcome allegedly improperly shifted to affiliates in other countries from 1989 to 1996.
A federal court has upheld a patent on Allergan's anti-inflammatory eye drug Acular, a decision that could block Apotex's generic equivalent from going to market until 2009.
The FDA hopes to determine which scientific and technical issues are the most disputed during current Good Manufacturing Practice (cGMP) and preapproval inspections through a year long pilot project meant to test the agency’s draft formal dispute resolution guidance.
A federal judge has removed a hurdle in Endo Pharmaceuticals’ plan to launch a generic version of Purdue’s pain drug OxyContin, while GlaxoSmithKline (GSK) recently threw up a roadblock in Dr. Reddy’s bid to market a version of GSK’s profitable migraine treatment Imitrex.
NaPro BioTherapeutics did not obtain its formulation patents for a generic version of paclitaxel through inequitable conduct and fraud, a federal court ruled late December.