New Drug Approvals Archive - July 2017
New Indication Approved: June 30, 2017
- Bristol-Myers Squibb’s Orencia (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis in Adults
Read more: Orencia (abatacept) FDA Approval History
Endari (L-glutamine) Oral Powder
Date of Approval: July 7, 2017
Company: Emmaus Life Sciences Inc.
Treatment for: Sickle Cell Anemia
Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid formulation to relieve pain, swelling and other complications of sickle cell anemia.
Read more: Endari (L-glutamine) FDA Approval History
New Indication Approved: July 11, 2017
- FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
Read more: Blincyto (blinatumomab) FDA Approval History
Tremfya (guselkumab) Injection
Date of Approval: July 13, 2017
Company: Janssen Biotech, Inc.
Treatment for: Plaque Psoriasis
Tremfya (guselkumab) is an interleukin-23 blocker indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
- Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis
Read more: Tremfya (guselkumab) FDA Approval History
Nerlynx (neratinib) Tablets
Date of Approval: July 17, 2017
Company: Puma Biotechnology, Inc.
Treatment for: Breast Cancer -- Adjuvant
Nerlynx (neratinib) is a tyrosine kinase inhibitor for the extended adjuvant treatment of early-stage HER2-positive breast cancer.
- FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
Read more: Nerlynx (neratinib) FDA Approval History
Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Tablets
Date of Approval: July 18, 2017
Company: Gilead Sciences, Inc.
Treatment for: Chronic Hepatitis C
Vosevi (sofosbuvir, velpatasvir and voxilaprevir or SOF/VEL/VOX) is a fixed-dose combination of a nucleotide analog NS5B polymerase inhibitor (SOF), a pangenotypic NS5A inhibitor (VEL), and a pangenotypic NS3/4A protease inhibitor (VOX) for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.
- FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
New Formulation Approved: July 20, 2017
- GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus
Read more: Benlysta (belimumab) FDA Approval History
Patient Population Altered: July 21, 2017
- FDA Expands Approval of Yervoy (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma
Read more: Yervoy (ipilimumab) FDA Approval History
New Indication Approved: July 26, 2017
Read more: Fycompa (perampanel) FDA Approval History
Abilify Maintena (aripiprazole)
New Indication Approved: July 27, 2017
- Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension Approved by the U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder