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New Drug Approvals Archive - November 2014

November 2014

November 5	Cyramza (ramucirumab) Labeling Revision Approved: November 5, 2014 FDA Approves Cyramza (ramucirumab) in Combination with Paclitaxel for Advanced Gastric Cancer after Prior Chemotherapy Cyramza (ramucirumab) FDA Approval History
November 5	Olysio (simeprevir) Labeling Revision Approved: November 5, 2014 FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection Olysio (simeprevir) FDA Approval History
November 13	Invega Sustenna (paliperidone palmitate) New Indication Approved: November 13, 2014 FDA Approves sNDA for Invega Sustenna (paliperidone palmitate) for Schizoaffective Disorder Invega Sustenna (paliperidone palmitate) FDA Approval History
November 14	Avastin (bevacizumab) New Indication Approved: November 14, 2014 FDA Approves Avastin (bevacizumab) Plus Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer Avastin (bevacizumab) FDA Approval History
November 14	Lemtrada (alemtuzumab) Injection Date of Approval: November 14, 2014 Company: Genzyme Treatment for: Multiple Sclerosis Lemtrada (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS). FDA Approves Lemtrada (alemtuzumab) for Relapsing Forms of Multiple Sclerosis Lemtrada (alemtuzumab) FDA Approval History
November 17	Auryxia (ferric citrate) Labeling Revision Approved: November 17, 2014 Keryx Biopharmaceuticals Announces Trade Name Auryxia for Ferric Citrate Auryxia (ferric citrate) FDA Approval History
November 20	Hysingla ER (hydrocodone bitartrate) Extended-Release Tablets Date of Approval: November 20, 2014 Company: Purdue Pharma L.P. Treatment for: Chronic Pain Hysingla ER (hydrocodone) is a single-entity (without acetaminophen) extended-release opioid analgesic for around-the-clock management of moderate to severe chronic pain. FDA Approves Hysingla ER - Extended-Release Hydrocodone with Abuse-Deterrent Properties Hysingla ER (hydrocodone bitartrate) FDA Approval History
November 25	Onexton (benzoyl peroxide and clindamycin phosphate) Gel Date of Approval: November 25, 2014 Company: Valeant Pharmaceuticals International, Inc. Treatment for: Acne Onexton (benzoyl peroxide and clindamycin phosphate) is an antimicrobial and lincosamide antibacterial combination for the once-daily topical treatment of acne vulgaris. Valeant Pharmaceuticals Announces FDA Approval of Onexton Gel for Acne Vulgaris Onexton (benzoyl peroxide and clindamycin phosphate) FDA Approval History

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