Wednesday, October 23, 2013

Recent Outpatient Drug Approvals through August 2013


The greatest impact for your trend will likely be the new cancer agents that continue to allow treatment to move from inpatient to outpatient settings.[1]


Addiction

Zubsolv (buprenorphine and naloxone) Sublingual Tablets
Company: Orexo AB
Date of Approval: July 3, 2013
Treatment for: Opiate Dependence
Zubsolv (buprenorphine and naloxone) is a sublingual partial opioid agonist indicated for the maintenance treatment of opioid dependence.

Cancer

Gilotrif (afatinib) Tablets
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Date of Approval: July 12, 2013
Treatment for: Non-Small Cell Lung Cancer
Gilotrif (afatinib) is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).
Mekinist (trametinib) Tablets
Company: GlaxoSmithKline
Date of Approval: May 29, 2013
Treatment for: Melanoma - Metastatic
Mekinist (trametinib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
Tafinlar (dabrafenib) Capsules
Company: GlaxoSmithKline
Date of Approval: May 29, 2013
Treatment for: Melanoma - Metastatic
Tafinlar (dabrafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

Cardiovascular

Epaned (enalapril) Powder for Oral Solution
Company: Silvergate Pharmaceuticals Inc.
Date of Approval: August 13, 2013
Treatment for: Hypertension
Epaned (enalapril) is an angiotensin-converting enzyme inhibitor indicated for the treatment of hypertension in adults and children older than one month.

Depression

Fetzima (levomilnacipran) Extended-Release Capsules
Company: Forest Laboratories, Inc. and Pierre Fabre Laboratories
Date of Approval: July 25, 2013
Treatment for: Depression
Fetzima (levomilnacipran) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.
Khedezla (desvenlafaxine) Extended-Release Tablets
Company: Osmotica Pharmaceutical Corp.
Date of Approval: July 10, 2013
Treatment for: Depression
Khedezla (desvenlafaxine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.

Endocrine

Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) Tablets
Company: Warner Chilcott plc
Date of Approval: July 24, 2013
Treatment for: Contraception
Lo Minastrin Fe (ethinyl estradiol and norethindrone, ethinyl estradiol, and ferrous fumarate) is an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.
Brisdelle (paroxetine mesylate) Capsules - formerly LDMP
Company: Noven Pharmaceuticals, Inc.
Date of Approval: June 28, 2013
Treatment for: Hot Flashes Associated with Menopause
Brisdelle (paroxetine mesylate) is a low-dose selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

Epilepsy

Trokendi XR (topiramate)
Company: Supernus Pharmaceuticals, Inc.
Date of Approval: August 16, 2013
Treatment for: Epilepsy
Trokendi XR (topiramate) is an antiepileptic drug indicated for the treatment of epilepsy.

Hemophilia

Rixubis (coagulation factor IX (recombinant)) Injection
Company: Baxter International Inc.
Date of Approval: June 26, 2013
Treatment for: Hemophilia B
Rixubis (coagulation factor IX, recombinant) is an antihemophilic factor indicated for the control and prevention of bleeding episodes in adults with hemophilia B.

HIV Infection

Tivicay (dolutegravir) Tablets
Company: ViiV Healthcare
Date of Approval: August 12, 2013
Treatment for: HIV Infection
Tivicay (dolutegravir) is an integrase inhibitor indicated for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1.
·         FDA Approves Tivicay (dolutegravir) to Treat HIV Infection - August 12, 2013

Organ Transplant

Astagraf XL (tacrolimus) Extended-Release Capsules
Company: Astellas Pharma US, Inc.
Date of Approval: July 19, 2013
Treatment for: Organ Transplant -- Rejection Prophylaxis
Astagraf XL (tacrolimus) is a calcineurin-inhibitor immunosuppressant for the prophylaxis of organ rejection in patients receiving a kidney transplant.

Respiratory

Breo Ellipta (fluticasone and vilanterol) Inhalation Powder
Company: GlaxoSmithKline plc (GSK) and Theravance, Inc.
Date of Approval: May 10, 2013
Treatment for: Chronic Obstructive Pulmonary Disease
Breo Ellipta (fluticasone and vilanterol) is a once-a-day inhaled corticosteroid/long-acting beta2 agonist (LABA) combination indicated for the treatment of patients with chronic obstructive pulmonary disease (COPD).
Source:  Drugs.com

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