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

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

• 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