New Drug Approvals Archive - July 2017

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

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

Nerlynx (neratinib) is a tyrosine kinase inhibitor indicated:

• as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
• in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

• 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