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