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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Nocdurna (desmopressin acetate) Sublingual Tablets

Company: Ferring Pharmaceuticals Inc.
Date of Approval: June 21, 2018
Treatment for: Nocturia

Nocdurna (desmopressin acetate) is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults.

Nocdurna FDA Approval History

moxidectin Tablets

Company: Medicines Development for Global Health
Date of Approval: June 13, 2018
Treatment for: Onchocerciasis

Moxidectin is a macrocyclic lactone anthelmintic medicine indicated for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older.

moxidectin FDA Approval History

Fulphila (pegfilgrastim-jmdb) Injection

Company: Mylan N.V.
Date of Approval: June 4, 2018
Treatment for: Neutropenia Associated with Chemotherapy

Fulphila (pegfilgrastim-jmbd) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy.

Fulphila FDA Approval History

Consensi (amlodipine and celecoxib) Tablets - formerly KIT-302

Company: Kitov Pharma Ltd.
Date of Approval: May 31, 2018
Treatment for: Hypertension, Osteoarthritis

Consensi (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination for the treatment of both hypertension and pain associated with osteoarthritis.

Consensi FDA Approval History

Palynziq (pegvaliase-pqpz) Injection

Company: BioMarin Pharmaceutical Inc.
Date of Approval: May 24, 2018
Treatment for: Phenylketonuria

Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria.

Palynziq FDA Approval History

Yonsa (abiraterone acetate) Tablets

Company: Sun Pharmaceutical Industries Inc.
Date of Approval: May 22, 2018
Treatment for: Prostate Cancer

Yonsa (abiraterone acetate) is an ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga) used in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer.

Yonsa FDA Approval History

Doptelet (avatrombopag) Tablets

Company: Dova Pharmaceuticals, Inc.
Date of Approval: May 21, 2018
Treatment for: Thrombocytopenia

Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical procedure.

Doptelet FDA Approval History

Aimovig (erenumab-aooe) Injection

Company: Amgen Inc.
Date of Approval: May 17, 2018
Treatment for: Migraine Prophylaxis

Aimovig (erenumab-aooe) is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of migraine.

Aimovig FDA Approval History

Lucemyra (lofexidine hydrochloride) Tablets

Company: US WorldMeds
Date of Approval: May 16, 2018
Treatment for: Opiate Withdrawal

Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal.

Lucemyra FDA Approval History

Retacrit (epoetin alfa-epbx) for Injection

Company: Hospira, Inc.
Date of Approval: May 15, 2018
Treatment for: Anemia

Retacrit (epoetin alfa-epbx) is an erythropoiesis-stimulating agent (ESA) biosimilar to Epogen/Procrit (epoetin alfa) indicated for treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

Retacrit FDA Approval History

Plenvu (polyethylene glycol 3350 with electrolytes) for Oral Solution

Company: Salix Pharmaceuticals, Inc.
Date of Approval: May 4, 2018
Treatment for: Bowel Preparation

Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride) is a lower-volume, polyethylene glycol based osmotic laxative indicated for cleansing of the colon (bowel preparation) prior to colonoscopy.

Plenvu FDA Approval History

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo)

Company: Portola Pharmaceuticals, Inc.
Date of Approval: May 3, 2018
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Andexxa FDA Approval History

Jynarque (tolvaptan) Tablets

Company: Otsuka Pharmaceutical Co., Ltd
Date of Approval: April 23, 2018
Treatment for: Adults at Risk of Rapidly Progressing Autosomal Dominant Polycystic Kidney Disease

Jynarque (tolvaptan) is a selective vasopressin V2-receptor antagonist indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Jynarque FDA Approval History

Akynzeo for Injection (fosnetupitant and palonosetron)

Company: Helsinn Healthcare SA
Date of Approval: April 19, 2018
Treatment for: Nausea/Vomiting -- Chemotherapy Induced

Akynzeo for Injection (fosnetupitant and palonosetron) is a substance P/neurokinin-1 (NK-1) receptor antagonist and serotonin-3 (5-HT3) receptor antagonist combination indicated for use with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Akynzeo for Injection FDA Approval History

Crysvita (burosumab-twza) Injection

Company: Ultragenyx Pharmaceutical Inc.
Date of Approval: April 17, 2018
Treatment for: X-Linked Hypophosphatemia

Crysvita (burosumab-twza) is a fibroblast growth factor 23 (FGF23) blocking antibody for the treatment of x-linked hypophosphatemia (XLH).

Crysvita FDA Approval History

Tavalisse (fostamatinib) Tablets

Company: Rigel Pharmaceuticals, Inc.
Date of Approval: April 17, 2018
Treatment for: Idiopathic (Immune) Thrombocytopenic Purpura

Tavalisse (fostamatinib) is an oral spleen tyrosine kinase (SYK) inhibitor for the treatment of patients with chronic immune thrombocytopenia (ITP).

Tavalisse FDA Approval History

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) Tablets

Company: Mylan Pharmaceuticals Inc.
Date of Approval: March 22, 2018
Treatment for: HIV Infection

Symfi (efavirenz, lamivudine and tenofovir disoproxil fumarate) is a three-drug combination of a non-nucleoside reverse transcriptase inhibitor (efavirenz), and two nucleo(t)side reverse transcriptase inhibitors (lamivudine and tenofovir disoproxil fumarate) indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Symfi FDA Approval History
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