The FDA has taken action against 17 companies that are illegally selling unapproved and/or misbranded products that claim to prevent, treat, or cure Alzheimer disease and other serious diseases and health conditions.
Zogenix announced the submission of a New Drug Application to the FDA for Fintepla oral solution for the treatment of seizures associated with Dravet syndrome.
In preclinical models, the inhibition of phosphorylated STAT3 (p-STAT3) by WP1066 resulted in the direct attack of various tumor cells.
Levetiracetam Injection, an antiepileptic, is indicated as adjunct therapy in patients aged ≥16 years with partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures, when oral administration is temporarily not feasible.
The blood-based in vitro test provides clinicians with initial screening information to determine the need for further diagnostic testing.
As treatment with vigabatrin may be associated with permanent vision loss, the generic tablets are also part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) program to ensure the product is used safely.
Apadaz was initially approved in February 2018 as 6.12mg/325mg immediate-release tablets for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Bafiertam is a new fumarate bioequialent alternative to its prodrug, Tecfidera (dimethyl fumarate; Biogen).
In the Phase 3 JET8 study (N=318), patients underwent a circadian challenge of 8 hours in advance to their usual bedtime.
Requip and Requip XL are non-ergot dopamine agonists indicated for the treatment of Parkinson disease.
