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The production, sale and distribution of Pravachol and generic pravastatin sodium by Bristol-Myers Squibb (BMS) and Watson Pharmaceuticals are being challenged in federal court.
The FDA is sending more than 1,100 letters to pharmaceutical companies advising them to reevaluate pharmacokinetic studies conducted by contract company MDS Pharma Services because the results may be invalid.
German company Altana has completed the sale of its pharmaceutical business to Danish drugmaker Nycomed for approximately $6 billion, Altana announced.
Ranbaxy Pharmaceuticals won final FDA approval to market atenolol, a generic version of AstraZeneca's hypertension drug Tenormin, the company announced.
The legalities and overall effect of special out-of-court settlements that result in lengthening the period of exclusivity for a brand drug by stalling generic entry are up for debate on Capitol Hill as members of the Senate Judiciary Committee plan to hold a hearing tentatively scheduled for next week, congressional sources say.
The FDA issued an approvable letter for Nuvo's topical non-steroidal anti-inflammatory drug Pennsaid to treat osteoarthritis of the knee, the company announced.
VaxGen announced that it will cut 51 percent of its work force as part of restructuring efforts, following the federal government's unilateral cancellation of what would have been an $877.5 million contract to develop a next-generation anthrax vaccine.
A federal appeals court in Canada rejected an appeal filed by Apotex to overturn a judgment that blocks the company from obtaining regulatory clearance needed to market clopidogrel bisulfate, a generic version of Bristol-Myers-Squibb's (BMS) heart drug, Plavix, BMS and sanofi-aventis said Dec. 28.
A Beijing court has ordered the three local drug manufacturers in China to pay a $38,000 fine, apologize publicly and stop making counterfeit versions of Pfizer's blockbuster impotence drug, Viagra, a company spokesman said.