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 |
|---|---|---|---|
| 7/2/2020 | Byfavo | Cosmo Pharmaceuticals | induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less |
| 7/6/2020 | Rukobia | ViiV | for 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 |
| 7/8/2020 | Inqovi | Astex Pharmaceuticals | to treat adults with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) |
| 7/9/2020 | Qwo | Endo International | treatment of moderate to severe cellulite in the buttocks of adult women |
| 7/9/2020 | Dysport | Ipsen | for the Treatment of Spasticity in Children |
| 7/9/2020 | Botox | Allergan / AbbVie | treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy |
| 7/9/2020 | Upneeq | Osmotica Pharmaceuticals | for Acquired Blepharoptosis (Droopy Eyelid) in Adults |
| 7/9/2020 | Hulio | Mylan / Kyowa Kirin | Multiple indications |
| 7/14/2020 | Tremfya | Janssen | adult patients with active psoriatic arthritis (PsA) |
| 7/22/2020 | Xywav | Jazz | treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy |
| 7/22/2020 | WATCHMAN FLX | Boston Scientific | as an alternative to oral anticoagulation (OAC) therapy in patients with nonvalvular atrial fibrillation (AF) |
| 7/22/2020 | Wynzora Cream | MC2 Therapeutics | once-daily topical treatment of plaque psoriasis in adults 18 years of age or older |
| 7/23/2020 | Qutenza | Averitas Pharma | patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults |
| 7/24/2020 | Breztri Aerosphere | AstraZeneca | maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
| 7/24/2020 | Tecartus | Kite Pharma (Gilead Owned) | CAR T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) |
| 7/27/2020 | Xeglyze | Dr. Reddy’s Laboratories | topical treatment of head lice infestation in patients 6 months of age and older |
| 7/29/2020 | VENTANA HER2 Dual ISH | Roche | detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy |
| 7/31/2020 | Tecentriq + Cotellic + Zelboraf | Genentech | treatment of BRAF V600 mutation-positive advanced melanoma |
| 8/3/2020 | Spravato | Janssen | to treat depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior |
| 8/3/2020 | Monjuvi | MorphoSys US | treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) |
| 8/3/2020 | Epidiolex | Greenwich Biosciences | treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age and older |
| 8/6/2020 | Blenrep | GlaxoSmithKline | treatment 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 |
| 8/7/2020 | Evrysdi | Roche and PTC Therapeutics | treatment of adults and children at least 2 months old who have spinal muscular atrophy (SMA) |
| 8/7/2020 | Lampit | Bayer | for 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) |
| 8/10/2020 | Olinvyk | Trevena | management of moderate to severe acute pain in adults who require an IV opioid and for whom alternative treatments fail |
| 8/10/2020 | Guardant360 CDx assay | Guardant Health | for 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 |
| 8/12/2020 | Viltepso | NS Pharma | for 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 |
| 8/17/2020 | Enspryng | Genentech | for adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) |
| 8/20/2020 | Kesimpta | Novartis | for 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 |
| 8/27/2020 | Winlevi | Cassiopea | treatment of acne vulgaris in patients aged 12 years and older |
| 8/28/2020 | Sogroya | Novo Nordisk | for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD) |
| 8/31/2020 | Xaracoll | Innocoll Holdings Limited | for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair |
| 9/2/2020 | Onureg | Bristol Myers Squibb | maintenance therapy for patients with acute myeloid leukemia (AML) who have achieved a first complete remission |
| 9/7/2020 | Gavreto | Genentech | treatment of patients with metastatic non–small cell lung cancer (NSCLC) that tests positive for rearranged during transfection (RET) fusions |
| 9/8/2020 | Qdolo | Athena Bioscience | in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
| 9/8/2020 | Trelegy Elipta | GlaxoSmithKline | treatment of asthma in patients aged 18 years and older |
| 9/25/2020 | Nucala | GlaxoSmithKline | for 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 |
| 9/25/2020 | Alaway Preservative Free | Bausch Health / Eton Pharmaceuticals | the 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 |
| 9/25/2020 | Kalydeco | Vertex | for 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 |
| 9/28/2020 | Xeljanz | Pfizer | treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA) |
| 9/28/2020 | Fetroja | Shionogi | treatment 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 |
| 9/28/2020 | Haegarda | CSL Behring | for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in patients 6 years of age and older |
| 9/29/2020 | Alkindi Sprinkle | Eton Pharmaceuticals | replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age |
| 9/30/2020 | Simponi Aira | Janssen | for 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.
