New Drug Approvals Archive - July 2017

Orencia (abatacept)

New Indication Approved: June 30, 2017

• Bristol-Myers Squibb’s Orencia (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis in Adults
• 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.

• FDA Approves Endari (L-glutamine oral powder) for Sickle Cell Disease
• Endari (L-glutamine) FDA Approval History

Blincyto (blinatumomab)

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
• 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
• 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
• 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
• Vosevi (sofosbuvir, velpatasvir and voxilaprevir) FDA Approval History

Benlysta (belimumab)

New Formulation Approved: July 20, 2017

• GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus
• Benlysta (belimumab) FDA Approval History

Yervoy (ipilimumab)

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
• Yervoy (ipilimumab) FDA Approval History

Fycompa (perampanel)

New Indication Approved: July 26, 2017

• FDA Approves Additional Use of Antiepileptic Drug Fycompa as Monotherapy for Partial-onset Seizures
• 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
• Abilify Maintena (aripiprazole) FDA Approval History