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New Drug Approvals Archive - July 2018

See also: New Indications and Dosage Forms for July 2018

July 2018

TPOXX (tecovirimat) Capsules and Injection

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: Servier Pharmaceuticals
Treatment for: Acute Myeloid Leukemia, Cholangiocarcinoma of Biliary Tract

Tibsovo (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor used in the treatment of patients with IDH1-mutated acute myeloid leukemia (AML) and IDH1-mutated cholangiocarcinoma.

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.

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