December 2019 FDA Approvals

Pharmacy Times, January 2020, Volume 86, Issue 1

See all 120 FDA New Drug Application approvals from December 2019.

Drug Name

Indication

Manufacturer

Date Approved

Mequinol; Tretinoin (Solage)

Solar Lengtigines

Almirall

Dec 2, 2019

Uridine Triacetate (Xuriden)

Hereditary orotic aciduria

Wellstat Therapies

Dec 2, 2019

Apomorphine Hydrochloride (Apokyn)

Loss of muscle movement caused by Parkinsons Disease

US Worldmeds

Dec 3, 2019

Mecasermin Recombinant (Increlex)

Growth delay in children lacking insulin-like growth factor-1

Ipsen Inc.

Dec 3, 2019

Bedaquiline Fumarate (Sirturo)

Active Tuberculosis

Janssen Therapies

Dec 3, 2019

Tolvaptan (Jynarque)

Autosomal Dominant Polycystic Kidney Disease

Otsuka Pharms Co LTD

Dec 3, 2019

Emtricitabine; Tenofovir Alafenamide Fumarate (Descovy)

HIV Prophylactic

Gilead Sciences

Dec 3, 2019

Emtricitabine; Rilpivirine Hydrochloride (Odefsey)

HIV Treatment

Gilead Sciences

Dec 3, 2019

Technetrium TC-99M Sestamibi Kit (Cardiolite/Miraluma)

Myocardial Perfusion Agent

Lantheus Medical

Dec 4, 2019

Thalidomide (Thalomid)

Treatment and prevention for skin disease caused by leprosy

Celgene

Dec 4, 2019

Icodextrin (Extraneal)

Colloid osmotic agent for peritoneal dialysis

Baxter Healthcare

Dec 4, 2019

Lurasidone Hydrochloride (Latuda)

Antipsychotic

Sunovion Pharms Inc

Dec 4, 2019

Ledipasvir; Sofosbuvir (Harvoni)

Hepatitis C Treatment

Gilead Sciences Inc

Dec 4, 2019

Sofosbuvir (Sovaldi)

Hepatitis C Treatment

Gilead Sciences Inc

Dec 4, 2019

Cinacalcet Hydrochloride (Sensipar)

Calcium Reducer

Amgen

Dec 5, 2019

Carbidopa; Levodope (Duopa)

Treatment for Parkinson's Disease

Abbvie Inc

Dec 5, 2019

Paclitaxel (Abraxane)

Treatment for lung, ovarian, and breast cancers

Abraxis Bioscience

Dec 6, 2019

Argatroban in Sodium Chloride

Prophylaxis for or treatment of thrombosis

Eagle Pharms

Dec 6, 2019

Tobramycin (Kitabis Pak)

Treatment for persistent lung infection in patients with cystic fibrosis

Pulmoflow Inc

Dec 6, 2019

Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir (Viekira Pak)

Hepatitis C Treatment

Abbvie Inc

Dec 6, 2019

Ombitasvir; Paritaprevir; Ritonavir (Technivie)

Hepatitis C Treatment

Abbvie Inc

Dec 6, 2019

Naproxen Sodium

Anti-inflammatory

BionPharma Inc

Dec 9, 2019

Unidose Liquid System

Nasal rescue treatment for acute repetitive seizures in patients with epilepsy

AptarGroup Inc

Dec 9, 2019

Tobramycin (Bethkis)

Treatment for patients with cystic fibrosis with pseudomonas aeruginosa

Chiesi USA Inc

Dec 9, 2019

Isavuconazonium Sulfate (Cresemba)

Systemic antifungal medication

Astellas

Dec 9, 2019

Valacyclovir Hydrochloride (Valtrex)

Antiviral

Glaxosmithkline

Dec 10, 2019

Bupropion Hydrochloride (Forfivo XL)

Smoking cessation aid and antidepressant

Alvogen

Dec 10, 2019

Radium RA-223 Dichloride (Xofigo)

Treatment for prostate cancer

Bayer Healthcare

Dec 10, 2019

Desvenlafaxine Fumarate (Desvenlafaxine)

Antidepressant

Sun Pharma Global

Dec 10, 2019

Dipyridamole (Persantine)

Vasodilator and blood thinner

Boehringer Ingelheim

Dec 11, 2019

Aspirin; Dipyridamole (Aggrenox)

Vasodilator and blood thinner

Boehringer Ingelheim

Dec 11, 2019

Acyclovir; Hydrocortisone (Xerese)

Steroid and antiviral

Bausch

Dec 11, 2019

Aspirin (Vazalore)

Aspirin therapy for patients with vascular disease or diabetes

PLX Pharm

Dec 11, 2019

Dimethyl Fumarate (Tecfidera)

Relapsing Multiple Sclerosis

Biogen Idec Inc

Dec 11, 2019

Oritavancin Diphosphate (Orbactiv)

Treatment of serious gram-positive bacterial infections

Melinta Therapies

Dec 11, 2019

Elbasvir; Grazoprevir (Zepatier)

Hepatitis C treatment

Merck Sharp Dohme

Dec 11, 2019

Estradiol (Divigel)

Hormone for symptoms caused by menopause of removal of the ovaries

Vertical Pharms LLC

Dec 12, 2019

Purified Water (Pur-Wash)

Eye cleansing for relief from irritation or burning

Niagara Pharms

Dec 12, 2019

Tofacitinib Citrate (Xeljanz)

Treatment for ulcerative colitis

PF Prism CV

Dec 12, 2019

Carbamazepine (Carnexiv)

Replacement therapy for oral carbamazepine formulations

Lundbeck Pharms LLC

Dec 12, 2019

Golodirsen (Vyondys 53)

Treatment for Duchenne Muscular Dystrophy

Sarepta Therapeutics Inc

Dec 12, 2019

Bromocriptine Mesylate (Parlodel)

Dopamine Promoter

US Pharms Holdings

Dec 13, 2019

Cabergoline (Dostinex)

Dopamine Promoter

Pharmacia and UpJohn

Dec 13, 2019

Fondaparinux Sodium (Arixtra)

Blood thinner

Mylan Ireland LTD

Dec 13, 2019

Sopropterin Dihydrochloride (Kuvan)

Dietary Supplement

BioMarin Pharm

Dec 13, 2019

Cetirizine Hydrochloride Allergy

Antihistamine

BionPharma Inc

Dec 13, 2019

Mycophenolate Mofetil (Cellcept)

Immunosuppressive drug

Roche Palo

Dec 13, 2019

Icosapent Ethyl (Vascepta)

Treatment for hypertriglyceridemia

Amarin Pharms

Dec 13, 2019

Ceftolozane Sulfate; Tazobactam Sodium (Zerbaxa)

Combination antibiotic for complicated UTIs and intra-abdominal infections

Cubist Pharms LLC

Dec 13, 2019

Vancomycin Hydrochloride (Firvanq Kit)

Treatment for Clostridium difficile infections

Rxmtm Therapeutics LLC

Dec 13, 2019

Riluzole (Tiglutik Kit)

Treatment for amyotrophic lateral sclerosis

Italfarmaco Spa

Dec 13, 2019

Brexanolone (Zulresso)

Treatment for postpartum depression

Sage Therapeutics

Dec 13, 2019

Cysteine Hydrochloride (Nouress)

Additive to amino acids solutions to meet nutritional requirements for neonates

Avadel Legacy

Dec 13, 2019

Beractant (Survanta)

Used to treat or prevent respiratory distress syndrome in premature infants

Abbvie Inc

Dec 16, 2019

Poractant Alfa (Curosurf)

Used to treat or prevent respiratory distress syndrome in premature infants

Chiesi USA Inc

Dec 16, 2019

Albuterol Sulfate (Ventolin HFA)

Treatment of prevention of bronchospasm

Glaxosmithkline

Dec 16, 2019

Fluvoxamine Maleate (Luvox)

Treatment for patients with obsessive compulsive disorder

Ani Pharms

Dec 16, 2019

Iloprost (Ventavis)

Treatment of pulmonary arterial hypertension

Actelion Pharms LTD

Dec 16, 2019

Clindamycin Phosphate (Cleocin)

Antibiotic

Pharmacia and UpJohn

Dec 16, 2019

Topotecan Hydrochloride

Chemotherapy for ovarian, lung, and cervical cancers

Hospira Inc

Dec 16, 2019

Enzalutamide (Xtandi)

Treatment for advanced prostate cancer

Astellas

Dec 16, 2019

Docetaxel (Taxotere)

Treatment for various forms of cancer

Sanofi Aventis US

Dec 17, 2019

Paricalcitol

Treatment and prevention for overactive parathyroid glands in patients with chronic kidney disease who are on dialysis

Hospira Inc

Dec 17, 2019

Cabidopa; Levodopa (Rytary)

Intermittent treatment of off episodes in patients with Parkinsons disease

Impax Labs Inc

Dec 17, 2019

Calcifediol (Rayaldee)

Treatment of hyperparathyroidism in patients with stage 3/4 chronic kidney failure

Opko Ireland Global

Dec 17, 2019

Hydroxyurea (Droxia)

Reduces number of painful crises in patients with sickle cell anemia

Bristol Myers Squibb

Dec 18, 2019

Hydroxyurea (Hydrea)

Oral medication to treat several types of cancers

Bristol Myers Squibb

Dec 18, 2019

Pramlintide Acetate (Symlin)

Lowers amount of glucose produced by the liver

Astrazeneca AB

Dec 18, 2019

Amlodipine Besylate; Atorvastatin Calcium (Caduet)

Treatment for hypertension of angina

Pfizer

Dec 18, 2019

Bazeoxifene acetate; Estrogens (Duavee)

Short-term treatment for women after menopause to treat hot flashes

Wyeth Pharms

Dec 18, 2019

Acyclovir (Sitavig)

Treatment for cold sores

EPI Health

Dec 18, 2019

Propranolol Hydrochloride (Hemangeol)

Treats or prevents heart attack; reduces severity of migraines

Pierre Fabre Derma

Dec 18, 2019

Tazarotene (Arazlo)

Topical treatment for acne vulgaris

Dow Pharma

Dec 18, 2019

Technetium TC-99M Sulfur Colloid Kit (An-Sulfur Colloid)

Imaging agent for areas of functioning reticuleondothelial cells in liver, spleen, and bone marrow

Pharmalucence

Dec 19, 2019

Ritonavir (Norvir)

HIV Preventative

Abbvie Inc

Dec 19, 2019

Mometasone Furoate (Asmanex Twisthaler)

Maintenance Asthma Treatment

Merck Sharp Dohme

Dec 19, 2019

Lopinavir; Ritonavir (Kaletra)

Treatment for HIV-1

Abbvie Inc

Dec 19, 2019

Alvimopan (Entereg)

Opioid receptor antagonist

Cubist Pharms LLC

Dec 19, 2019

Saquinavir Mesylate (Invirase)

Treatment for HIV

Hoffmann-LA Roche

Dec 19, 2019

Dalfampridine (Ampyra)

Improves walking in adults with Multiple Sclerosis

Acorda

Dec 19, 2019

Baclofen (Gablofen)

Muscle relaxant

Piramal Critical

Dec 19, 2019

Osimertinib Mesylate (Tagrisso)

Interferes with the growth and spread of cancer cells

Astrazeneca Pharms

Dec 19, 2019

Insulin Aspart (Fiasp)

Improves blood sugar control in diabetes patients

NOVO

Dec 19, 2019

Enfortumab Vedotin-ejfv (Padcev)

Treatment of adults with locally advanced or metastatic urothelial cancer

Seattle Genetics, Inc.

Dec 19, 2019

Levamlodipine (Conjupri)

Treatment for hypertension

CPSC OUYI Pharma Co Ltd

Dec 19, 2019

Micafungin Sodium (Mycamine)

Antifungal

Astellas

Dec 20, 2019

Clofarabine (Clolar)

Interferes with the growth and spread of cancer cells

Genzyme

Dec 20, 2019

Doxycycline (Vibramycin)

Antibiotic

Pfizer

Dec 20, 2019

Duxorubicin Hydrochloride

Chemotherapy

Pharmacia and UpJohn

Dec 20, 2019

Glipizide

Anti-diabetic

Ani Pharms Inc

Dec 20, 2019

Florbetapir F-18 (Amyvid)

Imaging agent for PET scanning

Avid Radiopharms Inc

Dec 20, 2019

Nitric Ixide (Genosyl)

Vasodilator

Vero Biotech

Dec 20, 2019

Fam-trastuzumab deruxtecan-nxki (Enhertu)

Treatment for adults with unresectable or metastatic HER2-positive breast cancer

Daiichi-Sankyo

Dec 20, 2019

Lommitapide Mesylate (Juxtapid)

Cholesterol-lowering medication

Aegerion

Dec 20, 2019

Sumatriptan Succinate (Onzetra Xsail)

Migraine and cluster headache treatment

Currax

Dec 20, 2019

Lumateperone (Caplyta)

Antipsychotic for treatment of schizophrenia

Intra-cellular Therapies Inc

Dec 20, 2019

Brilliant Blue G (TissueBlue)

Ophthalmic solution for staining eye during surgery

Dutch Ophthalmic Research

Dec 20, 2019

Letermovir (Prevymis)

Prevention of disease caused by cytomegalovirus

Merck Sharp Dohme

Dec 20, 2019

Lemborexant (Dayvigo)

Treatment for insomnia

Eisai Inc

Dec 20, 2019

Medroxyprogesterone Acetate (Depo-Subq Provero 104)

Progestin for pregnancy prevention and management of endometriosis pain

Pharmacia and UpJohn

Dec 23, 2019

Carglumic Acid (Carbaglu)

Ammonia Reducer

Recordati Rare

Dec 23, 2019

Triamcinolone Acetonide (Zilretta)

Treats knee pain in patients with osteoarthritis

Flexion Therapies Inc

Dec 23, 2019

Ubrogepant (Ubrelvy)

Treatment for acute migrain attacks with or without aura)

Allergan

Dec 23, 2019

Ketaconazole (Xolegel)

Treatment for seborrheic dermatitis

Almirall

Dec 26, 2019

Valproic Acid (Stavzor)

Treatment for seizure disorders, mental/mood disorders, and migraine prevention

Bionpharma Inc

Dec 26, 2019

Sumatriptan Succinate (Sumavel Dosepro)

Treatment for migraine and cluster headaches

Endo Ventures Ltd

Dec 26, 2019

Fingolimod Hydrochloride (Gilenya)

Immunosuppressant

Novartis

Dec 26, 2019

Methotrexate (Otrexup)

Treats leukemia and breast, skin, head and neck, or lung cancers

Antares Pharms Inc

Dec 26, 2019

Doxycycline Hyclate (Acticlate)

Antibiotic

Almirall

Dec 26, 2019

Glatiramer Acetate (Copaxone)

Treatment for multiple sclerosis and prevention of relapse

Teva Pharmaceuticals USA

Dec 27, 2019

Insulin Detemir Recombinant (Levemir)

Improves blood sugar control in patients with diabetes

Novo Nordisk Inc

Dec 27, 2019

Guanfacine Hydrochloride (Intuniv)

Treatment for attention deficit hyperactivity disorder

Shire

Dec 27, 2019

Zudivudine

Antiretroviral medication to prevent and treat HIV/AIDS

Matrix Labs Inc

Dec 27, 2019

Prednisone (Rayos)

Treatment for arthritis, blood disorders, breathing problems, severe allergies, etc.

Horizon Pharma USA

Dec 27, 2019

Thiotepa (Tepadina)

Treats cancer by stopping or slowing growth of cancer cells

Adienne SA

Dec 27, 2019

Olaparib (Lynparza)

Interferes with growth and spread of cancer cells

Astrazeneca Pharms

Dec 27, 2019

Ivacaftor; Tezacaftor (Symdeko)

Treats cystic fibrosis

Vertex Pharms Inc

Dec 27, 2019

Nimodipine (Nymalize)

Prevents brain damage caused by aneurysm

Arbor Pharms LLC

Dec 28, 2019

Cabidopa; Entacapone; Levodopa (Stalevo)

Treatment for muscle stiffness, tremors, spasms, and poor muscle control caused by Parkinsons disease

Orion Pharma

Dec 30, 2019