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New Drug Approvals Archive - March 2017

March 2017

Odactra (house dust mite allergen extract) Sublingual Tablets

Date of Approval: March 1, 2017
Company: ALK-Abelló A/S
Treatment for: House Dust Mite Allergies

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.

Read more: Odactra (house dust mite allergen extract) FDA Approval History

Noctiva (desmopressin acetate) Nasal Spray

Date of Approval: March 3, 2017
Company: Serenity Pharmaceuticals, LLC
Treatment for: Nocturia

Noctiva (desmopressin acetate) is vasopressin analog nasal spray indicated for the treatment of nocturia due to nocturnal polyuria.

Read more: Noctiva (desmopressin acetate) FDA Approval History

Kisqali (ribociclib) Tablets - formerly LEE011

Date of Approval: March 13, 2017
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 indicated for the combination treatment of postmenopausal women with HR+/HER2- metastatic breast cancer.

Read more: Kisqali (ribociclib) FDA Approval History

Juvederm (dermal filler)

New Formulation Approved: March 20, 2017
Treatment for: Facial Rejuvenation

Read more: Juvederm (dermal filler) FDA Approval History

Xadago (safinamide) Tablets

Date of Approval: March 21, 2017
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

Read more: Xadago (safinamide) FDA Approval History

Bavencio (avelumab) Injection

Date of Approval: March 23, 2017
Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma; Urothelial Carcinoma

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and urothelial carcinoma.

Read more: Bavencio (avelumab) FDA Approval History

Symproic (naldemedine) Tablets

Date of Approval: March 23, 2017
Company: Shionogi Inc.
Treatment for: Opioid-Induced Constipation

Symproic (naldemedine) is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation.

Read more: Symproic (naldemedine) FDA Approval History

Zejula (niraparib) Capsules

Date of Approval: March 27, 2017
Company: Tesaro, Inc.
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the maintenance treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Read more: Zejula (niraparib) FDA Approval History

Dupixent (dupilumab) Injection

Date of Approval: March 28, 2017
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis.

Read more: Dupixent (dupilumab) FDA Approval History

Ocrevus (ocrelizumab) Injection

Date of Approval: March 28, 2017
Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal nerve cell damage. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

Read more: Ocrevus (ocrelizumab) FDA Approval History

Tagrisso (osimertinib)

Labeling Revision Approved: March 30, 2017

Read more: Tagrisso (osimertinib) FDA Approval History

Bavencio (avelumab)

New Indication Approved: May 9, 2017
Treatment for: Merkel Cell Carcinoma; Urothelial Carcinoma

Read more: Bavencio (avelumab) FDA Approval History

New Drug Approvals Archive