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