January – March 2024 | New Safety Information or Potential Signals of
Akeega (niraparib and abiraterone acetate)Zejula (niraparib)HaemorrhageFDA is evaluating the need for regulatory action.Certain amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate (generic product) Lack of...October – December 2024 | New Safety Information or Potential Signals
Alecensa (alectinib) capsulesAlunbrig (brigatinib) tabletsLorbrena (lorlatinib) tabletsZykadia (ceritinib) capsules; tabletsOptic neuropathyFDA is evaluating the need for regulatory action.AntidepressantsSelective serotonin reuptake inhibitors...April – June 2022 | New Safety Information or Potential Signals of Ser
The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this...October – December 2022 | New Safety Information or Potential Signals
Apretude (cabotegravir extended-release injectable suspension)Cabenuva (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular useVocabria (cabotegravir) Anaphylactic reactionThe “Adverse...July – September 2022 | New Safety Information or Potential Signals of
Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only, manufactured by ALK-Abelló, Inc.Certain product lots were associated with increased reports of false negative skin test results, with some cases of anaphylaxis from subsequent peanut...
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