New Drug Approvals Archive - October 2010

Aridol (mannitol) Inhalation Powder

Date of Approval: October 5, 2010
Company: Pharmaxis Ltd.
Treatment for: Bronchial Challenge Test

Aridol (mannitol inhalation powder) is a bronchial challenge test designed to help in the correct diagnosis and assessment of asthma.

• United States Food and Drug Administration Approves Aridol
• Aridol (mannitol) FDA Approval History

Atelvia (risedronate sodium) Delayed-Release Tablets

Date of Approval: October 8, 2010
Company: Warner Chilcott plc
Treatment for: Osteoporosis

Atelvia (risedronate sodium) is a bisphosphonate in a delayed-release formulation for treatment of postmenopausal osteoporosis.

• Warner Chilcott Announces FDA Approval of Atelvia - Next Generation Actonel
• Atelvia (risedronate sodium) FDA Approval History

Sorilux (calcipotriene) Foam

Date of Approval: October 7, 2010
Company: Stiefel Laboratories, Inc.
Treatment for: Psoriasis

Sorilux (calcipotriene) Foam is a vitamin D analog indicated for the topical treatment of plaque psoriasis in patients aged 18 years and older.

• Stiefel, a GSK company, Receives FDA Approval of Sorilux (calcipotriene) Foam, 0.005%
• Sorilux (calcipotriene) FDA Approval History

Vivitrol (naltrexone)

New Indication Approved: October 12, 2010

• FDA Approves Vivitrol to Treat Opioid-dependent Patients
• Vivitrol (naltrexone) FDA Approval History

Gamunex-C (immune globulin intravenous and subcutaneous) Injection

Date of Approval: October 13, 2010
Company: Talecris Biotherapeutics, Inc.
Treatment for: Primary Immunodeficiency Syndrome

Gamunex-C (immune globulin intravenous and subcutaneous) is indicated for the treatment of primary immunodeficiency (PI).

• Talecris Biotherapeutics Receives FDA Approval for Gamunex-C
• Gamunex-C (immune globulin intravenous and subcutaneous) FDA Approval History

H.P. Acthar Gel (corticotropin)

New Indication Approved: October 15, 2010
Treatment for: Infantile Spasms, Multiple Sclerosis exacerbations, Nephrotic Syndrome and others...

• FDA Approves H.P. Acthar Gel for the Treatment of Infantile Spasms

Botox (onabotulinumtoxinA)

New Indication Approved: October 15, 2010

• FDA Approves Botox to Treat Chronic Migraine

Baraclude (entecavir)

New Indication Approved: October 15, 2010

• U.S. Food and Drug Administration Approves Baraclude (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease
• Baraclude (entecavir) FDA Approval History

Pradaxa (dabigatran etexilate) Capsules

Date of Approval: October 19, 2010
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism

Pradaxa (dabigatran etexilate) is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; and for the treatment and reduction of risk of deep vein thrombosis and pulmonary embolism.

• FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
• Pradaxa (dabigatran etexilate) FDA Approval History

Bromday (bromfenac) Ophthalmic Solution - formerly XiDay

Date of Approval: October 16, 2010
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation

Bromday (bromfenac ophthalmic solution) is a once-daily ocular nonsteroidal anti-inflammatory agent for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

• ISTA Pharmaceuticals Receives FDA Approval for Bromday
• Bromday (bromfenac) FDA Approval History

Herceptin (trastuzumab)

New Indication Approved: October 20, 2010

• FDA Approves Herceptin For HER2-Positive Metastatic Stomach Cancer

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) Tablets

Date of Approval: October 21, 2010
Company: Warner Chilcott plc
Treatment for: Contraception

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

• Warner Chilcott Announces FDA Approval of New Oral Contraceptive Lo Loestrin Fe
• Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) FDA Approval History

Sprycel (dasatinib)

New Indication Approved: October 28, 2010

• FDA approves additional medical indication for Sprycel
• Sprycel (dasatinib) FDA Approval History

Latuda (lurasidone) Tablets

Date of Approval: October 28, 2010
Company: Dainippon Sumitomo Pharma America, Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Latuda (lurasidone) is an atypical antipsychotic agent for the treatment of schizophrenia and bipolar depression.

• FDA approves Latuda to treat schizophrenia in adults
• Latuda (lurasidone) FDA Approval History

Nuedexta (dextromethorphan and quinidine) - formerly Zenvia

Date of Approval: October 29, 2010
Company: Avanir Pharmaceuticals
Treatment for: Pseudobulbar Affect

Nuedexta (dextromethorphan and quinidine) is a first-in-class dual action glutamate inhibitor indicated for the treatment of pseudobulbar affect.

• Avanir Pharmaceuticals Announces FDA Approval of Nuedexta
• Nuedexta (dextromethorphan and quinidine) FDA Approval History

Teflaro (ceftaroline fosamil) Injection

Date of Approval: October 29, 2010
Company: Allergan, Inc.
Treatment for: Pneumonia, Skin and Structure Infection

Teflaro (ceftaroline fosamil) is a cephalosporin antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

• FDA Approves Teflaro for Bacterial Infections
• Teflaro (ceftaroline fosamil) FDA Approval History

Latuda (lurasidone)

New Indication Approved: June 28, 2013

• Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression
• Latuda (lurasidone) FDA Approval History

Pradaxa (dabigatran etexilate)

New Indication Approved: April 7, 2014

• FDA Approves Pradaxa for Deep Venous Thrombosis and Pulmonary Embolism
• Pradaxa (dabigatran etexilate) FDA Approval History

Pradaxa (dabigatran etexilate)

New Indication Approved: November 23, 2015

• FDA Approves Pradaxa for Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism after Hip Replacement Surgery
• Pradaxa (dabigatran etexilate) FDA Approval History

Teflaro (ceftaroline fosamil)

Patient Population Altered: May 27, 2016

• Allergan Receives FDA Approval of Teflaro (ceftaroline fosamil) for Pediatric Patients
• Teflaro (ceftaroline fosamil) FDA Approval History

Latuda (lurasidone)

Patient Population Altered: January 27, 2017

• Sunovion’s Latuda (lurasidone) Receives FDA Approval to Treat Adolescents with Schizophrenia
• Latuda (lurasidone) FDA Approval History

Latuda (lurasidone)

Patient Population Altered: March 5, 2018

• FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)
• Latuda (lurasidone) FDA Approval History