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New Drug Approvals Archive - January 2017

January 2017

Lucentis (ranibizumab)

New Indication Approved: January 5, 2017
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

Arymo ER (morphine sulfate) Extended-Release Tablets

Date of Approval: January 9, 2017
Company: Egalet Corporation
Treatment for: Pain

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation for the management of severe pain.

Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

Date of Approval: January 17, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Pain

Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

Trulance (plecanatide) Tablets

Date of Approval: January 19, 2017
Company: Synergy Pharmaceuticals Inc.
Treatment for: Constipation -- Chronic, Irritable Bowel Syndrome

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

Imbruvica (ibrutinib)

New Indication Approved: January 18, 2017
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma; Chronic Graft Versus Host Disease

Rhofade (oxymetazoline hydrochloride) Cream

Date of Approval: January 18, 2017
Company: Allergan plc
Treatment for: Acne Rosacea

Rhofade (oxymetazoline hydrochloride) is a topical alpha1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

AirDuo RespiClick (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma -- Maintenance

AirDuo RespiClick (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

ArmonAir RespiClick (fluticasone propionate) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma -- Maintenance

ArmonAir RespiClick (fluticasone propionate) is an inhaled corticosteroid in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

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