New Drug Approvals Archive - 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.

• FDA Approves Odactra for House Dust Mite Allergies

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.

• FDA Approves Noctiva (desmopressin acetate) Nasal Spray for Nocturia in Adults

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 a selective cyclin-dependent kinase inhibitor indicated for the combination treatment of postmenopausal women with HR+/HER2- metastatic breast cancer.

• FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer

Kisqali (ribociclib) FDA Approval History

Keytruda (pembrolizumab)

New Indication Approved: March 14, 2017

• FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)

Keytruda (pembrolizumab) FDA Approval History

Juvederm (dermal filler)

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

• FDA Approves Juvéderm Vollure XC for Correction of Facial Wrinkles and Folds in Adults

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.

• FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease

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.

• FDA Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma

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.

• FDA Approves Symproic (naldemedine) for the Treatment of Opioid-Induced Constipation

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.

• Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer

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.

• FDA Approves Dupixent (dupilumab) for Eczema

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.

• FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis

Ocrevus (ocrelizumab) FDA Approval History

Qudexy XR (topiramate)

New Indication Approved: March 29, 2017

• FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules to Include Prophylaxis of Migraine Headache in Adults and Adolescents

Qudexy XR (topiramate) FDA Approval History

Humira (adalimumab)

Labeling Revision Approved: March 27, 2017

• FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's Humira (adalimumab) Prescribing Information

Tagrisso (osimertinib)

Labeling Revision Approved: March 30, 2017

• Tagrisso (osimertinib) Receives FDA Full Approval

Tagrisso (osimertinib) FDA Approval History

Ibrance (palbociclib)

Labeling Revision Approved: March 31, 2017

• Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer

Ibrance (palbociclib) FDA Approval History

Bavencio (avelumab)

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

• FDA Grants Accelerated Approval to Bavencio (avelumab) for Urothelial Carcinoma

Bavencio (avelumab) FDA Approval History