New Drug Approvals Archive - September 2016

Blincyto (blinatumomab)

Patient Population Altered: August 30, 2016

• FDA Approves Blincyto (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Blincyto (blinatumomab) FDA Approval History

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).

• Shire Announces FDA Approval of Cuvitru [immune globulin subcutaneous (human)] for Primary Immunodeficiency

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.

• FDA Approves Yosprala (aspirin and omeprazole) for Secondary Prevention of Cardiovascular Disease in Patients at Risk for Aspirin-Associated Gastric Ulcers

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.

• FDA Approves Exondys 51 (eteplirsen) for Duchenne Muscular Dystrophy

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.

• FDA Approves Bayer's Kyleena (Levonorgestrel-Releasing Intrauterine System) for Prevention of Pregnancy for up to Five Years

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.

• KVK Tech Announces FDA-Approval of Lomaira (phentermine hydrochloride USP) for Weight Reduction

Lomaira (phentermine hydrochloride) FDA Approval History

Invokamet (canagliflozin and metformin)

New Dosage Form Approved: September 20, 2016

• FDA Approves Invokamet XR (Canagliflozin/Metformin Hydrochloride Extended-Release) for the Treatment of Adults with Type 2 Diabetes

Invokamet (canagliflozin and metformin) 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.

• FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Amjevita (adalimumab-atto) FDA Approval History

Ilaris (canakinumab)

New Indication Approved: September 23, 2016

• FDA Approves Expanded Indications for Ilaris (canakinumab) for Three Rare Periodic Fever Syndromes

Ilaris (canakinumab) FDA Approval History

Rexulti (brexpiprazole)

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

• U.S. FDA Approves Labeling Update of Rexulti (brexpiprazole) for Maintenance Treatment of Schizophrenia

Rexulti (brexpiprazole) FDA Approval History

Stelara (ustekinumab)

New Indication Approved: September 23, 2016

• FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease

Stelara (ustekinumab) FDA Approval History

Orkambi (ivacaftor and lumacaftor)

Patient Population Altered: September 28, 2016

• FDA Approves Orkambi (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation

Orkambi (ivacaftor and lumacaftor) FDA Approval History