New Drug Approvals Archive - April 2011

Caprelsa (vandetanib) Tablets

Date of Approval: April 6, 2011
Company: AstraZeneca
Treatment for: Thyroid Cancer

Caprelsa (vandetanib) is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable (non-operable) locally advanced or metastatic disease.

• FDA Approves Orphan Drug Vandetanib for Advanced Medullary Thyroid Cancer
• Caprelsa (vandetanib) FDA Approval History

Horizant (gabapentin enacarbil) Extended Release Tablets - formerly Solzira

Date of Approval: April 6, 2011
Company: GlaxoSmithKline and XenoPort, Inc.
Treatment for: Restless Legs Syndrome, Postherpetic Neuralgia

Horizant (gabapentin enacarbil) is a gabapentin prodrug indicated for the once-daily treatment of restless legs syndrome and postherpetic neuralgia.

• GlaxoSmithKline and XenoPort Receive FDA Approval for Horizant
• Horizant (gabapentin enacarbil) FDA Approval History

Invega (paliperidone)

Patient Population Altered: April 6, 2011

• Invega Approved as Treatment for Schizophrenia in Adolescents
• Invega (paliperidone) FDA Approval History

Actemra (tocilizumab)

New Indication Approved: April 15, 2011

• FDA Approves Actemra (tocilizumab) for the Treatment of Systemic Juvenile Idiopathic Arthritis (SJIA)
• Actemra (tocilizumab) FDA Approval History

Rituxan (rituximab)

New Indication Approved: April 19, 2011

• FDA Approves Rituxan to Treat Two Rare Disorders

Menactra (meningococcal conjugate vaccine)

Patient Population Altered: April 22, 2011

• FDA Approves Menactra to Prevent Meningococcal Disease in Infants and Toddlers
• Menactra (meningococcal conjugate vaccine) FDA Approval History

Duexis (famotidine and ibuprofen) Tablets

Date of Approval: April 23, 2011
Company: Horizon Pharma, Inc.
Treatment for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis

Duexis (ibuprofen and famotidine) is an NSAID and histamine H2-receptor antagonist combination indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper GI ulcers.

• Horizon Pharma Announces FDA Approval of Duexis (Ibuprofen/Famotidine)
• Duexis (famotidine and ibuprofen) FDA Approval History

Lamictal XR (lamotrigine)

Labeling Revision Approved: April 25, 2011

• FDA Approves Lamictal XR (Lamotrigine) for Conversion to Monotherapy for Treatment of Partial Seizures in Appropriate Patients
• Lamictal XR (lamotrigine) FDA Approval History

Zytiga (abiraterone) Tablets

Date of Approval: April 28, 2011
Company: Centocor Ortho Biotech Inc.
Treatment for: Prostate Cancer

Zytiga (abiraterone acetate) is a CYP17 inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.

• FDA Approves Zytiga for Late-Stage Prostate Cancer
• Zytiga (abiraterone) FDA Approval History

AndroGel (testosterone)

New Formulation Approved: April 29, 2011

• Abbott Receives U.S. FDA Approval for AndroGel 1.62% to Treat Men with Low Testosterone

Horizant (gabapentin enacarbil)

New Indication Approved: June 6, 2012

• GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
• Horizant (gabapentin enacarbil) FDA Approval History

Zytiga (abiraterone)

New Indication Approved: December 10, 2012

• FDA Expands Zytiga’s Use for Late-Stage Prostate Cancer
• Zytiga (abiraterone) FDA Approval History

Zytiga (abiraterone)

New Indication Approved: February 7, 2018

• Zytiga (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
• Zytiga (abiraterone) FDA Approval History