Clinical

Denise Myshko is your editorial contact for the Formulary Watch. She joined Formulary Watch as editor is June 2021 from Oncology Live. Prior to that, she was managing editor of PharmaVOICE, a trade publication in the pharmaceutical industry. Email: dmyshko@mjhlifesciences.com

Articles

With a PDUFA date of Aug. 4, 2022, the FDA plans to hold an advisory committee meeting on resubmitted data for Nuplazid in patients with Alzheimer's disease who have psychosis.

FDA Plans Advisory Committee for Nuplazid in Alzheimer’s Psychosis

Eprontia is the first liquid formulation of topiramate approved to both treat and prevent seizure.

FDA Approves Liquid Formulation of Seizure Medication

ZIMHI is the second product approved by the FDA to counteract opioid, and it is a high-dose naloxone expected to be launched in the first quarter of 2022.

FDA Approves ZIMHI to Treat Opioid Overdose

The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.

Alkermes Launches the Antipsychotic Lybalvi 

Submission is based on extrapolation analysis and results examining the effects of Rexulti in treating symptoms of schizophrenia in patients 13 to 17 years old. The FDA is expected to complete its review in December 2021.

Otsuka, Lundbeck Submit sNDA for Rexulti in Adolescents with Schizophrenia

The COX-2 inhibitor Anjeso, a faster-acting injectable formulation of meloxicam, reduces opioid use after surgery.

Non-opioid Pain Therapeutic Achieves More Than 100 Formulary Approvals

The Alzheimer's Association praises the approval but not the price tag. A Harvard Medical School professor who resigned from an FDA advisory committee says the OK "was probably the worst approval decision in recent U.S. history" in his resignation letter.

Bouquets and Brickbats for FDA OK of Alzheimer's Drug Aduhelm

Today's approval goes against the advice of an outside advisory committee.

FDA Greenlights Controversial Aducanumab, Biogen's Alzheimer’s Treatment

Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.

Management of antipsychotic medication polypharmacy

A review of drug therapies and research presented at the 2012 Scientific Session of the American Diabetes Association.

72nd American Diabetes Association Scientific Sessions: Clinical updates review findings on risk of malignancy with pioglitazone, as well as various risk factors associated with insulin glargine use

Psychiatry and Behavioral Health