Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
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Last year more than 300 children – mainly aged under 5 – died of acute kidney injury, deaths that were associated with contaminated medicines, the WHO said in a statement.
The Southeast Asian country temporarily banned sales of some syrup-based medications in October after it identified the presence in some products of ethylene glycol and diethylene glycol as possible factors for causing the illness.
