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: Mayne Pharma
Treatment for: Psoriasis

Sorilux (calcipotriene) is a vitamin D analog indicated for the topical treatment of plaque psoriasis in patients 12 years and older.

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

Pradaxa (dabigatran etexilate) Capsules and Oral Pellets

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

Pradaxa (dabigatran etexilate) is a direct thrombin inhibitor.
Pradaxa capsules are indicated:

• to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation
• for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days
• to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated
• for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery
• for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days
• to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.

Pradaxa oral pellets are indicated:

• for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days
• to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.

• 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

Marketing Status: Discontinued

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

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: Birth Control

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

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