Skip to Content

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 treatment of HIV-1 infection.

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 non-nucleoside reverse transcriptase inhibitor (NNRTI) and nucleoside analogue reverse transcriptase inhibitors combination indicated for the treatment of HIV-1 infection.

New Drug Approvals Archive

2021
January, February
2020
January, February, March, April, May, June, July, August, September, October, November, December
2019
January, February, March, April, May, June, July, August, September, October, November, December
2018
January, February, March, April, May, June, July, August, September, October, November, December
2017
January, February, March, April, May, June, July, August, September, October, November, December
2016
January, February, March, April, May, June, July, August, September, October, November, December
2015
January, February, March, April, May, June, July, August, September, October, November, December
2014
January, February, March, April, May, June, July, August, September, October, November, December
2013
January, February, March, April, May, June, July, August, September, October, November, December
2012
January, February, March, April, May, June, July, August, September, October, November, December
2011
January, February, March, April, May, June, July, August, October, November, December
2010
January, February, March, April, May, June, July, August, September, October, November, December
2009
January, February, March, April, May, June, July, August, September, October, November, December
2008
January, February, March, April, May, June, July, August, September, October, November, December
2007
January, February, March, April, May, June, July, August, September, October, November, December
2006
January, February, March, April, May, June, July, August, September, October, November, December
2005
January, February, March, April, May, June, July, August, September, October, November, December
2004
January, February, March, April, May, June, July, August, September, October, November, December
2003
January, February, March, April, May, June, July, August, September, October, November, December
2002
January, February, April, May, July, August, October, November, December

More News Resources

Subscribe to our Newsletter

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

Further information

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