New Drug Approvals Archive - January 2015

Gadavist (gadobutrol)

Patient Population Altered: December 29, 2014

• FDA Approves Gadavist (gadobutrol) as the First MRI Contrast Agent for Patients Less Than 2 Years

Gadavist (gadobutrol) FDA Approval History

Bellafill (dermal filler)

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

• Bellafill Receives FDA Approval for the Treatment of Acne Scars

Bellafill (dermal filler) FDA Approval History

Rytary (carbidopa and levodopa) Extended Release Capsules - formerly IPX066

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.

• Impax Pharmaceuticals Announce FDA Approval of Rytary (carbidopa and levodopa) for Parkinson's Disease

Rytary (carbidopa and levodopa) FDA Approval History

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.

• FDA Approves Savaysa (edoxaban) to Prevent Embolic Events in Non-Valvular Atrial Fibrillation

Savaysa (edoxaban) FDA Approval History

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.

• FDA Approves Duopa (carbidopa and levodopa) Enteral Suspension for Parkinson's Disease

Duopa (carbidopa and levodopa) FDA Approval History

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).

• Baxter Receives FDA Approval for Phoxillum Solution for Electrolyte Management During Continuous Renal Replacement Therapy

Phoxillum (renal replacement solution) FDA Approval History

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.

• FDA Approves Cosentyx (secukinumab) for Plaque Psoriasis

Cosentyx (secukinumab) FDA Approval History

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.

• FDA Approves Prestalia (amlodipine and perindopril) for Hypertension

Prestalia (amlodipine besylate and perindopril arginine) FDA Approval History

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.

• FDA Approves Natpara (parathyroid hormone) for Hypocalcemia in Patients with Hypoparathyroidism

Natpara (parathyroid hormone) FDA Approval History

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.

• FDA Approves Bexsero Vaccine to Prevent Serogroup B Meningococcal Disease

Bexsero (meningococcal group B vaccine) FDA Approval History

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.

• FDA Approves Triferic for Iron Replacement and Maintenance of Hemoglobin in Hemodialysis Patients

Triferic (ferric pyrophosphate citrate) FDA Approval History

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

• FDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia

Imbruvica (ibrutinib) FDA Approval History

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.

• FDA Approves Evotaz (atazanavir and cobicistat) for HIV-1 Infection in Adults

Evotaz (atazanavir and cobicistat) FDA Approval History

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.

• FDA Approves Prezcobix (darunavir and cobicistat) for HIV-1 Infection in Adults

Prezcobix (cobicistat and darunavir) FDA Approval History

Vyvanse (lisdexamfetamine dimesylate)

New Indication Approved: January 30, 2015

• FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder

Vyvanse (lisdexamfetamine dimesylate) FDA Approval History

Zohydro ER (hydrocodone)

New Formulation Approved: January 30, 2015

• Zogenix Receives FDA Approval for New Abuse-Deterrent Formulation of Zohydro ER

Zohydro ER (hydrocodone) FDA Approval History

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.

• Alcon Receives FDA Approval of Pazeo (olopatadine HCl) Ophthalmic Solution for Allergic Conjunctivitis

Pazeo (olopatadine hydrochloride) FDA Approval History

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.

• FDA Approves Glyxambi (empagliflozin and linagliptin) for Type 2 Diabetes

Glyxambi (empagliflozin and linagliptin) FDA Approval History

Cosentyx (secukinumab)

New Indication Approved: January 15, 2016

• Novartis Receives FDA Approval for Cosentyx (secukinumab) to Treat Patients with Ankylosing Spondylitis and Psoriatic Arthritis

Cosentyx (secukinumab) FDA Approval History