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New Drug Approvals Archive - September 2016

September 2016

Cuvitru (immune globulin subcutaneous (human)) Injection

Date of Approval: September 13, 2016
Company: Shire plc
Treatment for: Primary Immunodeficiency Syndrome

Cuvitru (immune globulin subcutaneous (human)) is indicated as replacement therapy in the treatment of primary humoral immunodeficiency (PI).

Read more: Cuvitru (immune globulin subcutaneous (human)) FDA Approval History

Yosprala (aspirin and omeprazole) Delayed-Release Tablets

Date of Approval: September 14, 2016
Company: Aralez Pharmaceuticals Inc.
Treatment for: Ischemic Stroke -- Prophylaxis, Gastric Ulcer Prophylaxis

Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

Read more: Yosprala (aspirin and omeprazole) FDA Approval History

Exondys 51 (eteplirsen) Injection

Date of Approval: September 19, 2016
Company: Sarepta Therapeutics
Treatment for: Duchenne Muscular Dystrophy

Exondys 51 (eteplirsen) is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

Read more: Exondys 51 (eteplirsen) FDA Approval History

Kyleena (levonorgestrel) Releasing Intrauterine System

Date of Approval: September 16, 2016
Company: Bayer
Treatment for: Contraception

Kyleena (levonorgestrel-releasing intrauterine system) is a low-dose progestin-containing intrauterine system (IUS) indicated for the prevention of pregnancy for up to five years.

Read more: Kyleena (levonorgestrel) FDA Approval History

Lomaira (phentermine hydrochloride) Tablets

Date of Approval: September 13, 2016
Company: KVK Tech, Inc.
Treatment for: Weight Loss, Obesity

Lomaira (phentermine hydrochloride) is a sympathomimetic amine anorectic used short-term for weight reduction in overweight or obese adults.

Read more: Lomaira (phentermine hydrochloride) FDA Approval History

Amjevita (adalimumab-atto) Injection - formerly ABP 501

Date of Approval: September 23, 2016
Company: Amgen Inc.
Treatment for: Plaque Psoriasis, Rheumatoid Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohn's Disease -- Maintenance, Psoriatic Arthritis

Amjevita (adalimumab-atto) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Read more: Amjevita (adalimumab-atto) FDA Approval History

Rexulti (brexpiprazole)

Labeling Revision Approved: September 23, 2016
Treatment for: Schizophrenia; Major Depressive Disorder

Read more: Rexulti (brexpiprazole) FDA Approval History

New Drug Approvals Archive