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New Drug Approval ( 28 Sept 2018 – 30 October 2018)

Hyrimoz (adalimumab-adaz) Injection Date of Approval: October 30, 2018 Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease — Maintenance, Ulcerative Colitis, Plaque Psoriasis

Bijuva (estradiol and progesterone) Capsules Date of Approval: October 28, 2018 Treatment for: Menopausal Vasomotor Symptoms

Xofluza (baloxavir marboxil) Tablets Date of Approval: October 24, 2018 Treatment for: Influenza

Khapzory (levoleucovorin) for Injection Date of Approval: October 19, 2018 Treatment for: Methotrexate Rescue, Folic Acid Antagonist Overdose, Colorectal Cancer

Talzenna (talazoparib) Capsules Date of Approval: October 16, 2018 Treatment for: Breast Cancer

Yutiq (fluocinolone acetonide) Intravitreal Implant Date of Approval: October 12, 2018 Treatment for: Non-Infectious Posterior Segment Uveitis

Tegsedi (inotersen) Injection Date of Approval: October 5, 2018 Treatment for: Amyloidogenic Transthyretin Amyloidosis

Revcovi (elapegademase-lvlr) Injection Date of Approval: October 5, 2018 Treatment for: Adenosine Deaminase Severe Combined Immune Deficiency (ADA-SCID)

Nuzyra (omadacycline) for Injection and Tablets Date of Approval: October 2, 2018 Treatment for: Skin and Structure Infection, Pneumonia

Seysara (sarecycline) Tablets Date of Approval: October 1, 2018 Treatment for: Acne

Xyosted (testosterone enanthate) Subcutaneous Injection Date of Approval: September 28, 2018 Treatment for: Hypogonadism — Male

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