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New Drug Approvals Archive - October 2010

See also: New Indications and Dosage Forms for October 2010

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.

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.

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.

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).

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.

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.

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.

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.

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.

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).

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