New Drug Approvals Archive - January 2017

Lucentis (ranibizumab)

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

• FDA Approves Genentech’s Lucentis (ranibizumab) for Myopic Choroidal Neovascularization

Lucentis (ranibizumab) FDA Approval History

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.

• FDA Approves Arymo ER (morphine sulfate) Abuse-Deterrent Formulation for the Treatment of Chronic Pain

Arymo ER (morphine sulfate) FDA Approval History

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.

• Teva Receives FDA Approval for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets Formulated with Proprietary Abuse Deterrence Technology

Vantrela ER (hydrocodone bitartrate) FDA Approval History

Trulance (plecanatide) Tablets

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

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation in adults.

• FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation

Trulance (plecanatide) FDA Approval History

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

• U.S. FDA Approves Imbruvica (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL)

Imbruvica (ibrutinib) FDA Approval History

Rhofade (oxymetazoline hydrochloride) Cream

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

Rhofade (oxymetazoline hydrochloride) is a topical alpha_1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

• Allergan Announces FDA Approval of Rhofade (oxymetazoline hydrochloride) Cream for Facial Erythema Associated with Rosacea

Rhofade (oxymetazoline hydrochloride) FDA Approval History

Narcan (naloxone)

New Dosage Form Approved: January 24, 2017

• Narcan (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration

Narcan (naloxone) FDA Approval History

Symbicort (budesonide and formoterol)

Patient Population Altered: January 27, 2017

• Symbicort Approved for the Treatment of Asthma in Patients 6 to 12 Years of Age

Symbicort (budesonide and formoterol) FDA Approval History

Linzess (linaclotide)

New Dosage Form Approved: January 25, 2017

• U.S. FDA Approves 72 mcg Dose of Linzess (linaclotide) for Adults with Chronic Idiopathic Constipation

Linzess (linaclotide) 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

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.

• Teva Announces FDA Approval of AirDuo RespiClick (fluticasone propionate and salmeterol) for Maintenance Treatment of Asthma

AirDuo RespiClick (fluticasone propionate and salmeterol) FDA Approval History

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.

• Teva Announces FDA Approval of ArmonAir RespiClick (fluticasone propionate) for Maintenance Treatment of Asthma

ArmonAir RespiClick (fluticasone propionate) FDA Approval History