New Drug Approvals Archive - November 2012

Xarelto (rivaroxaban)

New Indication Approved: November 2, 2012

• FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots
• Xarelto (rivaroxaban) FDA Approval History

Xeljanz (tofacitinib) Tablets

Date of Approval: November 6, 2012
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis

Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and moderately to severely active ulcerative colitis.

• FDA Approves Xeljanz for Rheumatoid Arthritis
• Xeljanz (tofacitinib) FDA Approval History

Promacta (eltrombopag)

New Indication Approved: November 16, 2012

• FDA Approves New Indication for Promacta (eltrombopag)
• Promacta (eltrombopag) FDA Approval History

Flucelvax (influenza virus vaccine)

Date of Approval: November 20, 2012
Company: Novartis
Treatment for: Influenza Prophylaxis

Flucelvax (influenza virus vaccine) is an inactivated vaccine indicated for active immunization for the prevention of influenza.

• FDA Approves Flucelvax - First Seasonal Influenza Vaccine Manufactured Using Cell Culture Technology
• Flucelvax (influenza virus vaccine) FDA Approval History

Cometriq (cabozantinib) Capsules

Date of Approval: November 29, 2012
Company: Exelixis, Inc.
Treatment for: Thyroid Cancer

Cometriq (cabozantinib) is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer.

• FDA Approves Cometriq (cabozantinib) to Treat Rare Type of Thyroid Cancer
• Cometriq (cabozantinib) FDA Approval History

Xeljanz (tofacitinib)

New Dosage Form Approved: February 24, 2016

• Pfizer Announces FDA Approval of Xeljanz XR (tofacitinib citrate), the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis
• Xeljanz (tofacitinib) FDA Approval History

Xeljanz (tofacitinib)

New Indication Approved: December 14, 2017

• Pfizer Announces FDA Approval of Xeljanz (tofacitinib) and Xeljanz XR for the Treatment of Active Psoriatic Arthritis
• Xeljanz (tofacitinib) FDA Approval History

Xeljanz (tofacitinib)

New Indication Approved: May 30, 2018

• Pfizer Announces U.S. FDA Approves Xeljanz (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis
• Xeljanz (tofacitinib) FDA Approval History