FDA Updates – New Drug Approvals from Q3 2020

This blog series provides regular updates on new pharmaceutical products approved, new indications, and any other relevant changes. The new therapies in the list below may ultimately lead to new guideline updates in the future. You can find the recap or notable FDA drug changes (AdCom, PDUFDA, etc.) for July – September 2020 below. If we are missing information or you’d like more information about one of the noted changes, feel free to contact us.

Date Name Company Indication
7/2/2020ByfavoCosmo Pharmaceuticalsinduction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
7/6/2020RukobiaViiVfor use in combination with other antiretroviral (ARV) agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who fail to achieve viral suppression on other regimens due to resistance, intolerance, or safety considerations
7/8/2020InqoviAstex Pharmaceuticalsto treat adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML)
7/9/2020QwoEndo Internationaltreatment of moderate to severe cellulite in the buttocks of adult women
7/9/2020DysportIpsenfor the Treatment of Spasticity in Children
7/9/2020BotoxAllergan / AbbVietreatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy
7/9/2020UpneeqOsmotica Pharmaceuticalsfor Acquired Blepharoptosis (Droopy Eyelid) in Adults
7/9/2020HulioMylan / Kyowa KirinMultiple indications
7/14/2020TremfyaJanssenadult patients with active psoriatic arthritis (PsA)
7/22/2020XywavJazztreatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy
7/22/2020WATCHMAN FLXBoston Scientificas an alternative to oral anticoagulation (OAC) therapy in patients with nonvalvular atrial fibrillation (AF)
7/22/2020Wynzora CreamMC2 Therapeuticsonce-daily topical treatment of plaque psoriasis in adults 18 years of age or older
7/23/2020QutenzaAveritas Pharmapatch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults
7/24/2020Breztri AerosphereAstraZenecamaintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
7/24/2020TecartusKite Pharma (Gilead Owned)CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
7/27/2020XeglyzeDr. Reddy’s Laboratoriestopical treatment of head lice infestation in patients 6 months of age and older
7/29/2020VENTANA HER2 Dual ISHRochedetection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy
7/31/2020Tecentriq + Cotellic + ZelborafGenentechtreatment of BRAF V600 mutation-positive advanced melanoma
8/3/2020SpravatoJanssento treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior
8/3/2020MonjuviMorphoSys UStreatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
8/3/2020EpidiolexGreenwich Biosciencestreatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older
8/6/2020BlenrepGlaxoSmithKlinetreatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent
8/7/2020EvrysdiRoche and PTC Therapeuticstreatment of adults and children at least 2 months old who have spinal muscular atrophy (SMA)
8/7/2020LampitBayerfor use in pediatric patients (from birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi (T. cruzi)
8/10/2020OlinvykTrevenamanagement of moderate to severe acute pain in adults who require an IV opioid and for whom alternative treatments fail
8/10/2020Guardant360 CDx assayGuardant Healthfor use in patients with metastatic nonsmall cell lung cancer (NSCLC) to identify tumors with specific mutation types of the epidermal growth factor receptor (EGFR) gene
8/12/2020ViltepsoNS Pharmafor the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping
8/17/2020EnspryngGenentechfor adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD)
8/20/2020KesimptaNovartisfor the treatment of adults with relapsing forms of multiple sclerosis, including relapsing-remitting MS, active secondary progressive MS, and clinically isolated syndrome, the manufacturer announced in a press release
8/27/2020WinleviCassiopeatreatment of acne vulgaris in patients aged 12 years and older
8/28/2020SogroyaNovo Nordiskfor the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD)
8/31/2020XaracollInnocoll Holdings Limitedfor acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair
9/2/2020OnuregBristol Myers Squibbmaintenance therapy for patients with acute myeloid leukemia (AML) who have achieved a first complete remission
9/7/2020GavretoGenentechtreatment of patients with metastatic non–small cell lung cancer (NSCLC) that tests positive for rearranged during transfection (RET) fusions
9/8/2020QdoloAthena Biosciencein adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate
9/8/2020Trelegy EliptaGlaxoSmithKlinetreatment of asthma in patients aged 18 years and older
9/25/2020NucalaGlaxoSmithKlinefor the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause
9/25/2020Alaway Preservative FreeBausch Health / Eton Pharmaceuticalsthe first over-the-counter (OTC) preservative-free formulation eye drop approved to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
9/25/2020KalydecoVertexfor use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data
9/28/2020XeljanzPfizertreatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA)
9/28/2020FetrojaShionogitreatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens
9/28/2020HaegardaCSL Behringfor routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age and older
9/29/2020Alkindi SprinkleEton Pharmaceuticalsreplacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age
9/30/2020Simponi AiraJanssenfor patients 2 years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population

Stay tuned, as we will continue to update this FDA new drug approval series regularly. Our next update will cover Q4 2020, and will publish sometime in January 2021.

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