The Food and Drug Administration (FDA) issued a warning to Inova Genomics Laboratory for the illegal marketing of pharmacogenetic tests for predicting medication response to antidepressants, opioids, cancer therapy, anesthesia, and diabetes treatments. The warning letter describes how Inova’s MediMap tests are being falsely marketed to predict drug response to aid in making treatment decisions…
All articles by Da Hee Han, PharmD
Kyowa Hakko Kirin announced that the FDA has accepted the resubmitted NDA for istradefylline for use as adjunctive treatment to levodopa/carbidopa in adults with Parkinson disease experiencing OFF episodes.
Results from the phase 3b ALPINE study, which evaluated Aristada (aripiprazole lauroxil; Alkermes) and Invega Sustenna (paliperidone palmitate; Janssen) in patients experiencing an acute exacerbation of schizophrenia, showed that both of these long-acting injectable treatments effectively controlled schizophrenia symptoms
Luye Pharma Group announced the submission of a New Drug Application (NDA) for Rykindo (risperidone extended-release microsphere; LY03004) for Injectionto the Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar disorder.
The designation is given to potentially expedite development and review timelines for promising therapies.
Avanir announced data from the phase 3 clinical program that evaluated AVP-786 (deudextromethorphan hydrobromide/quinidine sulfate) for the treatment of moderate-to-severe agitation in patients with Alzheimer dementia.
The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication. Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It…
Drug overdoses resulted in approximately 72,000 deaths in the US, according to the CDC.
Eisai and Imbrium Therapeutics announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lemborexant, an investigational insomnia treatment.