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New Drug Approvals Archive - January 2015

January 2015

Bellafill (dermal filler)

New Indication Approved: December 23, 2014
Treatment for: Facial Wrinkles; Acne Scars

Rytary (carbidopa and levodopa) Extended Release Capsules

Date of Approval: January 7, 2015
Company: Impax Laboratories, Inc.
Treatment for: Parkinson's Disease

Rytary (carbidopa and levodopa) is an extended release aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination indicated for the treatment of Parkinson’s disease.

Savaysa (edoxaban) Tablets

Date of Approval: January 8, 2015
Company: Daiichi Sankyo Company
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Savaysa (edoxaban) is an oral, once-daily factor Xa inhibitor anticoagulant indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment of deep vein thrombosis, and pulmonary embolism.

Duopa (carbidopa and levodopa) Enteral Suspension

Date of Approval: January 12, 2015
Company: AbbVie Inc.
Treatment for: Parkinson's Disease

Duopa (carbidopa and levodopa) is an aromatic amino acid decarboxylation inhibitor and aromatic amino acid combination formulated as an enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson’s disease.

Phoxillum (renal replacement solution)

Date of Approval: January 13, 2015
Company: Baxter International Inc.
Treatment for: Continuous Renal Replacement Therapy

Phoxillum (renal replacement solution) is a replacement solution used for electrolyte management in Continuous Renal Replacement Therapy (CRRT).

Cosentyx (secukinumab) Injection

Date of Approval: January 21, 2015
Company: Novartis Pharmaceuticals Corporation
Treatment for: Plaque Psoriasis, Ankylosing Spondylitis, Psoriatic Arthritis

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.

Prestalia (amlodipine besylate and perindopril arginine) Tablets

Date of Approval: January 21, 2015
Company: Symplmed
Treatment for: Hypertension

Prestalia (amlodipine besylate and perindopril arginine) is a calcium channel blocker and long-acting angiotensin-converting enzyme (ACE) inhibitor combination for the treatment of hypertension.

Natpara (parathyroid hormone) Injection

Date of Approval: January 23, 2015
Company: NPS Pharmaceuticals, Inc.
Treatment for: Hypoparathyroidism

Natpara (parathyroid hormone) is recombinant human parathyroid hormone 1-84 indicated to control hypocalcemia in patients with hypoparathyroidism.

Bexsero (meningococcal group B vaccine) Injection

Date of Approval: January 23, 2015
Company: Novartis Vaccines and Diagnostics Inc.
Treatment for: Meningitis -- Meningococcal

Bexsero (meningococcal group B vaccine) is a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

Triferic (ferric pyrophosphate citrate) Solution

Date of Approval: January 23, 2015
Company: Rockwell Medical, Inc.
Treatment for: Anemia Associated with Chronic Renal Failure

Triferic (ferric pyrophosphate citrate) is an iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.

Imbruvica (ibrutinib)

New Indication Approved: January 29, 2015
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease

Evotaz (atazanavir and cobicistat) Tablets

Date of Approval: January 29, 2015
Company: Bristol-Myers Squibb Company
Treatment for: HIV Infection

Evotaz (atazanavir and cobicistat) is a once-daily fixed-dose combination of a protease inhibitor and a pharmacokinetic enhancer for the treatment of HIV-1 infection.

Prezcobix (cobicistat and darunavir) Tablets

Date of Approval: January 29, 2015
Company: Janssen Research & Development, LLC
Treatment for: HIV Infection

Prezcobix (darunavir and cobicistat) is a once-daily fixed-dose combination containing a protease inhibitor and a pharmacokinetic enhancer for the treatment of HIV-1 infection.

Pazeo (olopatadine hydrochloride) Ophthalmic Solution

Date of Approval: January 30, 2015
Company: Alcon Laboratories, Inc.
Treatment for: Allergic Conjunctivitis

Pazeo (olopatadine hydrochloride) is a mast cell stabilizer for the treatment of ocular itching associated with allergic conjunctivitis.

Glyxambi (empagliflozin and linagliptin) Tablets

Date of Approval: January 30, 2015
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company
Treatment for: Diabetes Type 2

Glyxambi (empagliflozin and linagliptin) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor combination for the treatment of adults with type 2 diabetes.

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