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.
