FDA Updates – New Drug Approvals from September and October 2019

This is a continuation of our new blog series to update you on recent FDA drug approvals, new indications, and other changes! You can find the recap or notable FDA drug changes (AdCom, PDUFDA, etc.) for September and October 2019 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
9/6/2019 Ofev Boehringer Ingelheim slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD
9/10/2019 Gvoke Xeris Pharmaceuticals treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above
9/12/2019 Nucala GlaxoSmithKline treatment for children as young as 6 years old with severe eosinophilic asthma
9/12/2019 HeartFlow Planner HeartFlow Inc a noninvasive virtual modeling tool for coronary artery disease (CAD) intervention, the company has announced.
9/12/2019 Ibsrela Ardelyx to treat irritable bowel syndrome with constipation (IBS-C) in adults
9/17/2019 Keytruda Merck treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation
9/18/2019 Erleada Janssen treatment of metastatic hormone-sensitive prostate cancer
9/20/2019 Rybelsus Novo Nordisk for adults with type 2 diabetes that along with diet and exercise may improve blood sugar
9/20/2019 Pifeltro Merck in combination with other antiretroviral medicines for use in people living with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed
9/20/2019 Delstrigo Merck in combination with other antiretroviral medicines for use in people living with HIV-1 who are switching from a stable antiretroviral regimen and whose virus is suppressed
9/24/2019 Jynneos Bavarian Nordic A/S prevention of smallpox and monkeypox disease in adults aged at least 18 years who have a high risk for either infection
9/26/2019 Mavyret AbbVie 8 week treatment-naive adults and children at least 12 years old or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection and compensated cirrhosis
9/26/2019 Darzalex Janssen in combination with the medicines Velcade® (bortezomib) + thalidomide + dexamethasone (DVTd) for adult patients with newly diagnosed multiple myeloma who can receive an autologous stem cell transplant.
9/27/2019 Rituxan Genentech in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older.
9/28/2019 Invokana Janssen to reduce the risk of end-stage kidney disease, worsening of kidney function, cardiovascular death, and heart failure hospitalization, in adults with type 2 diabetes and diabetic kidney disease
10/2/2019 Entresto Novartis treatment of symptomatic heart failure (HF) with systemic left ventricular systolic dysfunction in children 1 year and older
10/3/2019 Descovy Gilead HIV-1 preexposure prophylaxis (PrEP)
10/4/2019 Aklief Galderma once-daily topical treatment of acne vulgaris
10/4/2019 Fasenra Pen AstraZeneca adults and for children aged 12 years or older who have severe eosinophilic asthma
10/8/2019 Beovu Novartis treatment of wet age-related macular degeneration (AMD)
10/8/2019 Scenesse Clinuvel Pharmaceuticals

prevention of phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria

10/8/2019 Bonsity Pfenex treatment of osteoporosis in certain patients at high risk for fracture
10/10/2019 OraQuick Ebola Test OraSure rapid ebola testing
10/11/2019 Reyvow Eli Lilly treatment of acute migraine with or without aura in adults
10/14/2019 Xarelto Janssen to help prevent venous thromboembolism (VTE) and VTE-related death during hospitalization and post-hospital discharge in acutely ill medical patients at risk for VTE and not at high risk of bleeding
10/15/2019 Quzyttir JDP Therapeutics treatment of acute urticaria in adults and children 6 months of age or older
10/15/2019 Stellarex DCB Philips treatment of de novo and restenotic lesions in superficial femoral and popliteal arteries
10/15/2019 Secuado Noven Pharmaceuticals treatment of adults with schizophrenia
10/17/2019 Xofluza Genentech treatment of influenza for people at high risk of developing influenza-related complications.
10/18/2019 Amzeeq Foamix Pharmaceuticals Treatment of Moderate to Severe Acne
10/18/2019 Ultomiris Alexion treatment of atypical hemolytic uremic syndrome (aHUS)
10/21/2019 Farxiga AstraZeneca to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors
10/21/2019 Stelara Janssen treatment of adults with moderately to severely active ulcerative colitis
10/21/2019 Trikafta Vertex treatment of patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
10/22/2019 Cinvanti Heron Therapeutics Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)
10/22/2019 Nplate Amgen

treatment of adult patients with immune thrombocytopenia (ITP) who have had ITP for 12 months or less and an insufficient response to corticosteroids, immunoglobulins or splenectomy

10/22/2019 Fiasp Novo Nordisk insulin for use in insulin pumps in adults with type 1 or type 2 diabetes.
10/22/2019 Biorphen Eton Pharmaceuticals treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia
10/24/2019 Botox Allergan to ease lower-limb spasticity in children and adolescents aged 2 years to 17 years, excluding spasticity caused by cerebral palsy (CP)
10/24/2019 Zejula GlaxoSmithKline treatment of women whose advanced ovarian cancer is associated with homologous recombination deficiency
10/24/2019 Baxdela Melinta Community Acquired Bacterial Pneumonia
10/28/2019 Liletta Medicines360/Allergan prevention of pregnancy for up to six years
10/30/2019 Vumerity Biogen/Alkermes treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive disease


Stay tuned, as we will continue to update this FDA mew drug approval series once per month.

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