Product Sponsor Goal PDFUA Date Indication
Ofatumumab 2020-06 New use of the anti-CD20 monoclonal antibody (approved for leukemia as Arzerra for IV infusion) as a monthly subcutaneous injection self-administered by autoinjector pen for treatment of adults with relapsing forms of multiple sclerosis (RMS)
Adlarity (donepezil, transdermal) 2020-07-30 Once-weekly transdermal patch formulation of the cholinesterase inhibitor using Corium’s Corplex technology for treatment of dementia of the Alzheimer’s type in patients with mild, moderate and severe Alzheimer’s disease
Opicapone* 2020-04-26 Selective catechol-O-methyltransferase (COMT) inhibitor as once-daily oral adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes
APL-130277 (apomorphine sublingual film) 2020-05-21 Sublingual film formulation of the dopamine agonist using Aquestive’s PharmFilm technology for on-demand treatment of motor fluctuations (‘off’ episodes) in Parkinson’s disease (PD) patients
Risdiplam* 2020-05-24 Survival motor neuron-2 (SMN-2) splicing modifier formulated as an oral liquid for treatment of spinal muscular atrophy (SMA)