Skip to Content

New Drug Approvals Archive - July 2018

See also: New Indications and Dosage Forms for July 2018

July 2018

TPOXX (tecovirimat) Capsules

Date of Approval: July 13, 2018
Company: SIGA Technologies, Inc.
Treatment for: Smallpox

TPOXX (tecovirimat) is an orthopoxvirus-specific antiviral indicated for the treatment of human smallpox disease.

Symtuza (cobicistat, darunavir, emtricitabine and tenofovir alafenamide) Tablets

Date of Approval: July 17, 2018
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection

Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide) is a once daily, single-tablet regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.

Tibsovo (ivosidenib) Tablets

Date of Approval: July 20, 2018
Company: Agios Pharmaceuticals, Inc.
Treatment for: Acute Myeloid Leukemia

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with acute myeloid leukemia who have an IDH1 mutation.

Nivestym (filgrastim-aafi) Injection

Date of Approval: July 20, 2018
Company: Pfizer Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Febrile Neutropenia

Nivestym (filgrastim-aafi) is a recombinant human granulocyte colony-stimulating factor biosimilar to Neupogen indicated for the treatment of neutropenia associated with chemotherapy and related conditions.

Krintafel (tafenoquine) Tablets

Date of Approval: July 20, 2018
Company: GlaxoSmithKline
Treatment for: Malaria

Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

Orilissa (elagolix) Tablets

Date of Approval: July 23, 2018
Company: AbbVie, Inc.
Treatment for: Endometriosis

Orilissa (elagolix) is an orally administered gonadotropin-releasing hormone (GnRH) antagonist for the management of moderate to severe pain associated with endometriosis.

Perseris (risperidone) for Extended-Release Injectable Suspension

Date of Approval: July 27, 2018
Company: Indivior PLC
Treatment for: Schizophrenia

Perseris (risperidone) is a once-monthly, subcutaneous formulation of the approved atypical antipsychotic risperidone indicated for the treatment of schizophrenia in adults.

Azedra (iobenguane I 131) Injection

Date of Approval: July 30, 2018
Company: Progenics Pharmaceuticals Inc.
Treatment for: Pheochromocytoma; Paraganglioma

Azedra (iobenguane I 131) is a radioactive therapeutic agent for the treatment of locally advanced or metastatic pheochromocytoma and paraganglioma.

Mulpleta (lusutrombopag) Tablets

Date of Approval: July 31, 2018
Company: Shionogi Inc.
Treatment for: Thrombocytopenia

Mulpleta (lusutrombopag) is a once-daily, orally administered, thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical or dental procedure.

New Drug Approvals Archive

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.