New Drug Approvals Archive

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October 2010

October 5

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.

Aridol (mannitol) FDA Approval History

October 8

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.

Atelvia (risedronate sodium) FDA Approval History

October 7

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.

Sorilux (calcipotriene) FDA Approval History

October 13

Vivitrol (naltrexone)

New Indication Approved: October 12, 2010

Vivitrol (naltrexone) FDA Approval History

October 13

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).

Gamunex-C (immune globulin intravenous and subcutaneous) FDA Approval History

October 15

H.P. Acthar Gel (corticotropin)

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

October 15

Botox (onabotulinumtoxinA)

New Indication Approved: October 15, 2010

October 18

Baraclude (entecavir)

New Indication Approved: October 15, 2010

Baraclude (entecavir) FDA Approval History

October 19

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.

Pradaxa (dabigatran etexilate) FDA Approval History

October 16

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.

Bromday (bromfenac) FDA Approval History

October 20

Herceptin (trastuzumab)

New Indication Approved: October 20, 2010

October 21

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.

Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate) FDA Approval History

October 28

Sprycel (dasatinib)

New Indication Approved: October 28, 2010

Sprycel (dasatinib) FDA Approval History

October 28

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.

Latuda (lurasidone) FDA Approval History

October 29

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.

Nuedexta (dextromethorphan and quinidine) FDA Approval History

October 29

Teflaro (ceftaroline fosamil) Injection

Date of Approval: October 29, 2010
Company: Forest Laboratories, 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).

Teflaro (ceftaroline fosamil) FDA Approval History

July 1

Latuda (lurasidone)

New Indication Approved: June 28, 2013

Latuda (lurasidone) FDA Approval History

April 7

Pradaxa (dabigatran etexilate)

New Indication Approved: April 7, 2014

Pradaxa (dabigatran etexilate) FDA Approval History

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