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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.
Xcel Pharmaceuticals’ promotional materials for two migraine products omit risk information, make misleading comparative claims about safety and include unsubstantiated efficacy and indication claims, according to a letter from the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).
Responding to concerns from law enforcement officials, the Centers for Medicare & Medicaid Services (CMS) has extended the recordkeeping requirement for drug manufacturers from three to 10 years on an interim basis.
In a move that could bode well for drugmakers’ bottom line, Europe’s highest court yesterday ruled that German drugmaker Bayer AG did not violate European Union (E.U.) trade rules when it restricted shipments of its heart drug Adalat to certain E.U. states that set low drug prices.
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.
U.S. drug manufacturers intent on controlling the reimportation of drugs from Canada have won the support of the Canadian International Pharmacy Association (CIPA), which recently told a number of state and local agencies in the U.S. its 27-member mail-order pharmacy association will not engage in formal commercial agreements with them.
Manufacturers submitting stability data in support of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) need to identify the analytical procedures used to generate the data, according to a draft guidance released by the FDA yesterday.
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.
Roche is cautioning physicians not to prescribe its popular flu treatment to patients under a year old following recent animal safety trial results, according to a letter released on the FDA’s MedWatch website late Friday.