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New Drug Approvals Archive - May 2018

See also: New Indications and Dosage Forms for May 2018

May 2018

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo)

Date of Approval: May 3, 2018
Company: Portola Pharmaceuticals, Inc.
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Plenvu (polyethylene glycol 3350 with electrolytes) for Oral Solution

Date of Approval: May 4, 2018
Company: Salix Pharmaceuticals, Inc.
Treatment for: Bowel Preparation

Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride) is a lower-volume, polyethylene glycol based osmotic laxative indicated for cleansing of the colon (bowel preparation) prior to colonoscopy.

Retacrit (epoetin alfa-epbx) for Injection

Date of Approval: May 15, 2018
Company: Hospira Inc.
Treatment for: Anemia

Retacrit (epoetin alfa-epbx) is an erythropoiesis-stimulating agent (ESA) biosimilar to Epogen/Procrit (epoetin alfa) indicated for treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.

Lucemyra (lofexidine hydrochloride) Tablets

Date of Approval: May 16, 2018
Company: US WorldMeds
Treatment for: Opiate Withdrawal

Lucemyra (lofexidine hydrochloride) is a selective alpha 2-adrenergic receptor agonist indicated for reducing the severity of withdrawal symptoms in patients experiencing opioid withdrawal.

Aimovig (erenumab-aooe) Injection

Date of Approval: May 17, 2018
Company: Amgen Inc.
Treatment for: Migraine Prophylaxis

Aimovig (erenumab-aooe) is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of migraine.

Lokelma (sodium zirconium cyclosilicate) for Oral Suspension

Date of Approval: May 18, 2018
Company: AstraZeneca
Treatment for: Hyperkalemia

Lokelma (sodium zirconium cyclosilicate) is a potassium binder indicated for the treatment of hyperkalemia in adults.

Doptelet (avatrombopag) Tablets

Date of Approval: May 21, 2018
Company: Dova Pharmaceuticals, Inc.
Treatment for: Thrombocytopenia, Idiopathic (Immune) Thrombocytopenic Purpura

Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of:

  • Thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
  • Thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.

Yonsa (abiraterone acetate) Tablets

Date of Approval: May 22, 2018
Company: Sun Pharmaceutical Industries Ltd.
Treatment for: Prostate Cancer

Yonsa (abiraterone acetate) is an ultramicrosize formulation of the oral CYP17 inhibitor abiraterone acetate (approved as Zytiga) used in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer.

Palynziq (pegvaliase-pqpz) Injection

Date of Approval: May 24, 2018
Company: BioMarin Pharmaceutical Inc.
Treatment for: Phenylketonuria

Palynziq (pegvaliase-pqpz) is a phenylalanine-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria.

Imvexxy (estradiol) Vaginal Inserts - formerly TX-004HR

Date of Approval: May 29, 2018
Company: TherapeuticsMD, Inc.
Treatment for: Dyspareunia

Imvexxy (estradiol) is a bio-identical 17β-estradiol vaginal insert for the treatment of dyspareunia (vaginal pain during sexual intercourse) due to menopause.

Consensi (amlodipine and celecoxib) Tablets

Date of Approval: May 31, 2018
Company: Kitov Pharma Ltd.
Treatment for: Hypertension, Osteoarthritis

Consensi (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination for the treatment of both hypertension and pain associated with osteoarthritis.

Olumiant (baricitinib) Tablets

Date of Approval: May 31, 2018
Company: Eli Lilly and Company and Incyte Corporation
Treatment for: Rheumatoid Arthritis

Olumiant (baricitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis.

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