New Drug Approvals Archive - November 2014

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

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

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

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

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

Auryxia (ferric citrate)

Labeling Revision Approved: November 17, 2014

• Keryx Biopharmaceuticals Announces Trade Name Auryxia for Ferric Citrate
• Auryxia (ferric citrate) FDA Approval History

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

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