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Colorado-based Allos Therapeutics and three research organizations are suing Dr. Reddy’s over its proposed generic version of the brand manufacturer’s orphan lymphoma drug Folotyn. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More
The UK’s drug watchdog agency has recommended coverage of Biogen Idec’s oral multiple sclerosis drug Tecfidera, reversing its negative decision issued in February. Read More
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The FDA has asked Gilead Sciences to remove a sponsored link on Google that misrepresents the drugmaker’s hepatitis B drug, Viread, and omits risk information, the first such enforcement action since the agency issued guidance on character-limited advertisements last month. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
The FDA released two major guidances for compounding pharmacies. One establishes for the first time an interim GMP framework for large compounders that register with the agency as outsourced facilities. Read More
The FDA warned another compounding pharmacy for mixing unapproved drugs and for poor quality, with Pharmacy Creations becoming the latest compounder to challenge agency enforcement of its activities. Read More
Indian generics maker Ranbaxy will pay $2.3 million for selling drugs in Oregon that were manufactured in violation of current good manufacturing practices. Read More