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An FDA advisory panel is convening July 13 to discuss whether three lucrative asthma drugs should be pulled from the market because of safety concerns.
GlaxoSmithKline (GSK) has resumed U.S. sales of Paxil CR — a move that comes roughly four months after the firm voluntarily halted production of the antidepressant because of quality concerns.
The European Medicines Agency (EMEA) has formally recommended the continued suspension of Pfizer’s Cox-2 inhibitor Bextra, following the completion of a safety review that determined the drug’s risk-benefit ratio is unacceptable.
GlaxoSmithKline (GSK) has resumed U.S. sales of Paxil CR — a move that comes roughly four months after the firm voluntarily halted production of the antidepressant because of quality concerns.
Generic drugmaker Able Laboratories has suspended its manufacturing operations and recalled its full product line after an internal review of its operations revealed apparent departures from standard operating procedures.
Prescriptions for pain treatment Mobic have more than doubled since the withdrawal of competing drug Vioxx, according to an analysis by advocacy group Consumers Union, which also concluded that Mobic’s price is rising faster than most products in the non-steroidal anti-inflammatory drug (NSAID) class.
While the FDA has spent much of the past few months trumpeting the creation of its Drug Safety Oversight Board (DSB), critics are starting to question whether the board will have any true value.
The purpose of the FDA’s proposed Drug Watch website is to stimulate conversations between physicians and patients about treatment options, not generate sensational hype that may unnecessarily scare patients, according to top FDA officials.
The FDA is closely monitoring the recent recall by generic drugmaker Able Laboratories, which announced May 23 it was withdrawing its full product line because of quality control problems.