New Drug Approvals Archive - 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).

• FDA Approves Poteligeo (mogamulizumab-kpkc) for Mycosis Fungoides and Sézary Syndrome
• Poteligeo (mogamulizumab-kpkc) FDA Approval History

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.

• FDA Approves Arakoda (tafenoquine) for the Prevention of Malaria
• Arakoda (tafenoquine) FDA Approval History

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.

• FDA Approves Jornay PM (methylphenidate) Extended-Release Capsules for Attention Deficit Hyperactivity Disorder (ADHD)
• Jornay PM (methylphenidate hydrochloride) FDA Approval History

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).

• FDA Approves Onpattro (patisiran) Targeted RNA-based Therapy for Polyneuropathy Caused by hATTR
• Onpattro (patisiran) FDA Approval History

Annovera (ethinyl estradiol and segesterone acetate) Vaginal System

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

Marketing Status: Discontinued

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

• FDA Approves Annovera (segesterone acetate and ethinyl estradiol) Vaginal Contraceptive System
• Annovera (ethinyl estradiol and segesterone acetate) FDA Approval History

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.

• FDA Approves Galafold (migalastat) for the Treatment of Fabry Disease
• Galafold (migalastat) FDA Approval History

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).

• Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease
• Cequa (cyclosporine) FDA Approval History

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.

• FDA Approves Diacomit (stiripentol) for Seizures Associated with Dravet Syndrome
• Diacomit (stiripentol) FDA Approval History

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.

• FDA Approves Oxervate (cenegermin) for Neurotrophic Keratitis
• Oxervate (cenegermin-bkbj) FDA Approval History

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.

• FDA Approves Inveltys (loteprednol etabonate) for Post-Operative Inflammation and Pain Following Ocular Surgery
• Inveltys (loteprednol etabonate) FDA Approval History

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.

• FDA Approves Takhzyro (lanadelumab-flyo) for Hereditary Angioedema
• Takhzyro (lanadelumab-flyo) FDA Approval History

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.

• Ortho Dermatologics Receives FDA Approval for Altreno (tretinoin 0.05%) Lotion For Acne
• Altreno (tretinoin) FDA Approval History

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.

• Tetraphase Pharmaceuticals Announces FDA Approval of Xerava (eravacycline) for Complicated Intra-Abdominal Infections (cIAI)
• Xerava (eravacycline) FDA Approval History

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.

• Bayer Receives FDA Approval for Jivi (antihemophilic factor (recombinant), PEGylated-aucl) for Prophylactic Treatment of Hemophilia A
• Jivi (antihemophilic factor [recombinant] PEGylated-aucl) FDA Approval History

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.

• FDA Approves Merck’s Pifeltro (doravirine) for the Treatment of HIV-1 in Appropriate Patients
• Pifeltro (doravirine) FDA Approval History

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.

• FDA Approves Merck’s Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) for the Treatment of HIV-1 in Appropriate Patients
• Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate) FDA Approval History