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ZymoGenetics said the FDA has informed the company that it will not be required to conduct an additional Phase III clinical trial of its recombinant human Thrombin (rhThrombin), which aids in controlling bleeding during surgery.
Organizations representing more than 60,000 pharmacists sent a letter to three senators discouraging them from introducing a bill that would strengthen federal regulations on compounded drugs.
A five-year old patent infringement case filed by Apotex backfired when a federal court dismissed the case and ordered the company to pay $3.1 million in attorneys fees after finding its patent invalid.
Pfizer recently updated physician labeling in the European Union (EU) for antibacterial agent Zyvox to reflect safety restrictions for use in patients with serious catheter-related bloodstream infections, the company said.
The FDA has recommended that manufactures of sleep agents initiate clinical studies to determine the incidences of sleep-driving and other complex sleep behaviors that have been observed in postmarketing reports, the agency said March 14.
The FDA has cleared Pfizer's Lipitor for five new heart disease indications, including the reduction of the risk of hospitalization due to heart failure.
The FDA will conduct two studies to investigate how the context and format of risk information in direct-to-consumer (DTC) print advertisements influence consumers' understanding of drug risks.