Product Sponsor Goal PDFUA Date Indication Sacituzumab govitecan* (IMMU-132) 2020-06-02 Antibody drug conjugate (ADC) for treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease Opdivo (nivolumab) and Yervoy (ipilimumab) 2020-05-15 Combination immuno-oncology regimen of the PD-1 checkpoint inhibitor and a low dose of the CTLA4 inhibitor for first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) patients with no EGFR or ALK genomic tumor aberrrations, based on part 1 of the Phase III CheckMate-227 trial Xpovio (selinexor) 2020-06-23 New indication for the oral selective inhibitor [...]

Infectious Disease


Product Sponsor Goal PDFUA Date Indication Contepo (fosfomycin) 2020-06-19 Injectable formulation of the epoxide antibiotic with dosing regimen to optimize pharmacokinetics and pharmacodynamics for I.V. treatment of complicated urinary tract infections (cUTI) MenQuadfi (meningococcal vaccine*) 2020-04-25 Meningococcal (groups A, C, Y, W) polysaccharode tetanus toxoid conjugate vaccine for prevention of meningococcal meningitis in patients two years of age and older Recarbrio (relebactam, cilastatin and imipenem) 2020-06-04 New indication for the beta lactamase inhibitor and antibiotic combination for treatment of adults with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP)



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 [...]

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