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New Drug Approvals Archive - August 2018

See also: New Indications and Dosage Forms for August 2018

August 2018

Poteligeo (mogamulizumab-kpkc) Injection

Date of Approval: August 8, 2018
Company: Kyowa Hakko Kirin Co., Ltd.
Treatment for: Mycosis Fungoides; Sézary Syndrome

Poteligeo (mogamulizumab-kpkc) is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).

Arakoda (tafenoquine) Tablets

Date of Approval: August 8, 2018
Company: 60 Degrees Pharmaceuticals
Treatment for: Malaria Prophylaxis

Arakoda (tafenoquine) is an 8-aminoquinoline antimalarial drug indicated for the prophylaxis of malaria in patients aged 18 years and older.

Jornay PM (methylphenidate hydrochloride) Extended-Release Capsules

Date of Approval: August 8, 2018
Company: Ironshore Pharmaceuticals & Development, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Jornay PM (methylphenidate hydrochloride) is a once-daily formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Onpattro (patisiran) Injection

Date of Approval: August 10, 2018
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Hereditary Transthyretin-Mediated Amyloidosis (hATTR)

Onpattro (patisiran) is a small interfering ribonucleic acid (siRNA) therapeutic for the treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR).

Annovera (ethinyl estradiol and segesterone acetate) Vaginal System

Date of Approval: August 10, 2018
Company: The Population Council
Treatment for: Contraception

Annovera (ethinyl estradiol and segesterone acetate) is an estrogen and progestin vaginal contraceptive system indicated to prevent pregnancy for up to a year.

Galafold (migalastat) Capsules

Date of Approval: August 10, 2018
Company: Amicus Therapeutics
Treatment for: Fabry Disease

Galafold (migalastat) is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant.

Cequa (cyclosporine) Ophthalmic Solution

Date of Approval: August 14, 2018
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Keratoconjunctivitis Sicca

Cequa (cyclosporine) ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with dry eye disease (keratoconjunctivitis sicca).

Diacomit (stiripentol) Capsules and Powder for Oral Suspension

Date of Approval: August 20, 2018
Company: Biocodex
Treatment for: Dravet Syndrome

Diacomit (stiripentol) is an anticonvulsant indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.

Oxervate (cenegermin-bkbj) Ophthalmic Solution

Date of Approval: August 22, 2018
Company: Dompé farmaceutici SpA
Treatment for: Neurotrophic Keratitis

Oxervate (cenegermin) is a recombinant human nerve growth factor (rhNGF) ophthalmic solution indicated for the treatment of neurotrophic keratitis.

Inveltys (loteprednol etabonate) Ophthalmic Suspension

Date of Approval: August 22, 2018
Company: Kala Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Inveltys (loteprednol etabonate) is a nanoparticle ocular corticosteroid formulation for the treatment of post-operative ocular inflammation and pain.

Takhzyro (lanadelumab-flyo) Injection

Date of Approval: August 23, 2018
Company: Shire plc
Treatment for: Hereditary Angioedema

Takhzyro (lanadelumab-flyo) is a plasma kallikrein inhibitor (monoclonal antibody) for the prevention of angioedema attacks in patients with hereditary angioedema.

Altreno (tretinoin) Lotion

Date of Approval: August 23, 2018
Company: Ortho Dermatologics
Treatment for: Acne

Altreno (tretinoin) is a topical retinoid for the treatment of acne.

Xerava (eravacycline) Injection

Date of Approval: August 27, 2018
Company: Tetraphase Pharmaceuticals, Inc.
Treatment for: Complicated Intra-Abdominal Infections

Xerava (eravacycline) is a fluorocycline antibiotic indicated for the treatment of complicated intra-abdominal infections.

Jivi (antihemophilic factor [recombinant] PEGylated-aucl) Injection

Date of Approval: August 30, 2018
Company: Bayer HealthCare LLC
Treatment for: Hemophilia A

Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, Factor VIII concentrate indicated to treat and control bleeding in patients with hemophilia A.

Pifeltro (doravirine) Tablets

Date of Approval: August 30, 2018
Company: Merck
Treatment for: HIV Infection

Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the combination treatment of HIV-1 infection in adults.

Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) Tablets

Date of Approval: August 30, 2018
Company: Merck
Treatment for: HIV Infection

Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) a nonnucleoside reverse transcriptase inhibitor [NNRTI]) and nucleoside analogue reverse transcriptase inhibitors combination indicated as a complete regimen for the treatment of HIV-1 infection in adults.

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