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New Drug Approvals Archive - April 2011

April 2011

April 6

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.

Caprelsa (vandetanib) FDA Approval History

April 6

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.

Horizant (gabapentin enacarbil) FDA Approval History

April 11

Invega (paliperidone)

Patient Population Altered: April 6, 2011

Invega (paliperidone) FDA Approval History

April 17

Actemra (tocilizumab)

New Indication Approved: April 15, 2011

Actemra (tocilizumab) FDA Approval History

April 20

Rituxan (rituximab)

New Indication Approved: April 19, 2011

April 25

Menactra (meningococcal conjugate vaccine)

Patient Population Altered: April 22, 2011

Menactra (meningococcal conjugate vaccine) FDA Approval History

April 23

Duexis (famotidine and ibuprofen) Tablets - formerly Duexa

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.

Duexis (famotidine and ibuprofen) FDA Approval History

April 26

Lamictal XR (lamotrigine)

Labeling Revision Approved: April 25, 2011

Lamictal XR (lamotrigine) FDA Approval History

April 28

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.

Zytiga (abiraterone) FDA Approval History

April 29

AndroGel (testosterone)

New Formulation Approved: April 29, 2011

June 7

Horizant (gabapentin enacarbil)

New Indication Approved: June 6, 2012

Horizant (gabapentin enacarbil) FDA Approval History

December 10

Zytiga (abiraterone)

New Indication Approved: December 10, 2012

Zytiga (abiraterone) FDA Approval History

New Drug Approvals Archive