New Drug Approvals Archive - October 2018

Seysara (sarecycline) Tablets

Date of Approval: October 1, 2018
Company: Almirall, S.A.
Treatment for: Acne

Seysara (sarecycline) is an oral, narrow spectrum tetracycline-derived antibiotic for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

• FDA Approves Seysara (sarecycline) for the Treatment of Moderate to Severe Acne
• Seysara (sarecycline) FDA Approval History

Nuzyra (omadacycline) for Injection and Tablets

Date of Approval: October 2, 2018
Company: Paratek Pharmaceuticals, Inc.
Treatment for: Skin and Structure Infection, Pneumonia

Nuzyra (omadacycline) is an aminomethylcycline tetracycline antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

• FDA Approves Nuzyra (omadacycline) for Community-Acquired Bacterial Pneumonia and Acute Skin and Skin Structure Infections
• Nuzyra (omadacycline) FDA Approval History

Revcovi (elapegademase-lvlr) Injection

Date of Approval: October 5, 2018
Company: Leadiant Biosciences, Inc.
Treatment for: Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID).

• FDA Approves Revcovi (elapegademase-lvlr) for Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)
• Revcovi (elapegademase-lvlr) FDA Approval History

Tegsedi (inotersen) Injection

Date of Approval: October 5, 2018
Company: Ionis Pharmaceuticals, Inc.
Treatment for: Amyloidogenic Transthyretin Amyloidosis

Tegsedi (inotersen) is an antisense oligonucleotide inhibitor of the transthyretin (TTR) protein for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

• FDA Approves Tegsedi (inotersen) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis
• Tegsedi (inotersen) FDA Approval History

Yutiq (fluocinolone acetonide) Intravitreal Implant

Date of Approval: October 12, 2018
Company: EyePoint Pharmaceuticals, Inc.
Treatment for: Non-Infectious Posterior Segment Uveitis

Yutiq (fluocinolone acetonide) is a corticosteroid intravitreal implant indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

• FDA Approves Yutiq (fluocinolone acetonide intravitreal implant) for Chronic Non-Infectious Posterior Segment Uveitis
• Yutiq (fluocinolone acetonide) FDA Approval History

Talzenna (talazoparib) Capsules

Date of Approval: October 16, 2018
Company: Pfizer Inc.
Treatment for: Breast Cancer

Talzenna (talazoparib) is an oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.

• FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
• Talzenna (talazoparib) FDA Approval History

Khapzory (levoleucovorin) for Injection

Date of Approval: October 19, 2018
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Khapzory (levoleucovorin) is a folate analog indicated for:

• rescue after high-dose methotrexate therapy in patients with osteosarcoma
• diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
• treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

• Spectrum Pharmaceuticals Receives FDA Approval of Khapzory (levoleucovorin) for Injection
• Khapzory (levoleucovorin) FDA Approval History

Xofluza (baloxavir marboxil) Tablets and Granules for Oral Suspension

Date of Approval: October 24, 2018
Company: Genentech, Inc.
Treatment for: Influenza

Xofluza (baloxavir marboxil) is a polymerase acidic (PA) endonuclease inhibitor for the treatment of influenza, and for the post-exposure prophylaxis of influenza in people 12 years of age and older.

• FDA Approves Xofluza (baloxavir marboxil) for the Treatment of Acute Uncomplicated Influenza
• Xofluza (baloxavir marboxil) FDA Approval History

Bijuva (estradiol and progesterone) Capsules - formerly TX-001HR

Date of Approval: October 28, 2018
Company: TherapeuticsMD, Inc.
Treatment for: Menopausal Vasomotor Symptoms

Bijuva (estradiol and progesterone) is a bio-identical hormone combination for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) due to menopause.

• FDA Approves Bijuva (estradiol and progesterone) Capsules for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
• Bijuva (estradiol and progesterone) FDA Approval History

Hyrimoz (adalimumab-adaz) Injection

Date of Approval: October 30, 2018
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease -- Maintenance, Ulcerative Colitis, Plaque Psoriasis

Hyrimoz (adalimumab-adaz) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved for the treatment of various inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

• FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira
• Hyrimoz (adalimumab-adaz) FDA Approval History