Diana Ernst, RPh

The FDA has accepted for Priority Review the Biologics License Application for aducanumab for the treatment of Alzheimer disease.

The FDA has granted Priority Review of the supplemental New Drug Application for ticagrelor, for use in combination with aspirin, to reduce the rate of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack.

The FDA has approved Fintepla® (fenfluramine; Zogenix) oral solution for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

Higher doses of deutetrabenazine appear to be safe and well tolerated in patients with Huntington disease who may require them to adequately control chorea.

Treatment with deutetrabenazine was found to be beneficial for both younger (<55 years) and older (≥55 years) patients with tardive dyskinesia, according to findings from a recently published post hoc analysis.

Zeposia is available for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Lemborexant is now available for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.

The FDA has approved solifenacin succinate LS oral suspension for the treatment of neurogenic detrusor overactivity in pediatric patients 2 years of age and older.

This sublingual film formulation of apomorphine was designed for use as a fast-acting, on-demand treatment for all types of motor off episodes.

The FDA has approved Elyxyb (Dr. Reddy’s Laboratories), an oral solution formulation of celecoxib, for the acute treatment of migraine with or without aura in adults.

The Food and Drug Administration has approved Ongentys® as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease experiencing “off” episodes.

The FDA has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.

The supply of critical supportive medications such as opiods, sedatives, and paralytics needed for ventilating patients with COVID-19 is dwindling.

The product that sickened the couple was in powder form and was labeled “for Ornamental Fish Use Only.”

The mechanism by which it exerts therapeutic effects in MS is unknown but may involve the reduction of lymphocyte migration into the central nervous system.

The Food and Drug Administration has issued a statement regarding the use of nonsteroidal anti-inflammatory drugs in patients with coronavirus disease 2019.

The New Drug Application for ponesimod has been submitted to the Food and Drug Administration for the treatment of relapsing multiple sclerosis.

The use of electrical stimulation devices to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration.

Results showed a mean change from baseline of -9.28 points (95% CI, -10.23 to -8.32) on the HAM-A total score in patients treated with troriluzole compared with -9.35 points (95% CI, -10.34 to -8.36) with placebo (P =.917).

The FDA has expanded the approval of vigabatrin to include treatment of refractory complex partial seizures in patients aged 2 to <10 years of age.

Safety and efficacy was based on demonstration of bioequivalence to Oxycontin.

As a result of the vote, Nektar has decided to withdraw the New Drug Application for oxycodegol and to cease further development of the product.

The FDA has approved Valtoco (diazepam nasal spray; Neurelis) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 6 years of age and older.

In July 2017, Eagle had received a Complete Response Letter (CRL) from the FDA stating that an additional clinical trial would be needed prior to approval for the indication.

The FDA has granted Fast Track designation to AXER-204 (ReNetX Bio) for the potential treatment of chronic spinal cord injury.

The FDA has approved the first generic versions of fingolimod for the treatment of relapsing forms of multiple sclerosis in adults.

The FDA has approved Exservan (riluzole oral film; Aquestive Therapeutics) for the treatment of amyotrophic lateral sclerosis.

Recently announced results from part 2 of the SUNFISH trial, which evaluated the safety and efficacy of risdiplam in patients with type 2 or 3 SMA aged 2 to 25 years, showed that the treatment met its primary end point.

Although its exact mechanism in the treatment of partial-onset seizures is unknown, cenobamate has been shown to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.

Oliceridine, an investigational G-protein biased mu-opioid receptor ligand, was found to be safe and effective for acute pain management across diverse patient populations and surgeries, according to new phase 3 data.