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Financial Review
Pfizer Inc. and Subsidiary Companies
Regulatory approvals and filings in the EU and Japan:
PRODUCT
DESCRIPTION OF EVENT DATE
APPROVED
DATE FILED*
Tofacitinib Application filed in Japan for treatment of moderate-to-
severe active rheumatoid arthritis
— December 2011
Celebrex Approval in Japan for treatment of acute pain December 2011 —
Apixaban(a) Application filed in Japan for prevention of stroke and
systemic embolism in patients with non-valvular atrial
fibrillation
— December 2011
Vyndaqel (Tafamidis meglumine) Approval in the EU for treatment of TTR-FAP in adult
patients with stage 1 symptomatic polyneuropathy
November 2011 —
Tofacitinib Application filed in the EU for treatment of moderate-to-
severe active rheumatoid arthritis
— November 2011
Prevenar 13 Adult Approval in the EU for prevention of invasive
pneumococcal disease in adults 50 years of age and
older
October 2011 —
Sutent Application filed in Japan for treatment of pancreatic
neuroendocrine tumor
— October 2011
Lyrica Application filed in Japan for treatment of fibromyalgia — October 2011
ELIQUIS (Apixaban)(a) Application filed in the EU for prevention of stroke in
patients with atrial fibrillation
— October 2011
Bosutinib Application filed in the EU for treatment of newly
diagnosed chronic myelogenous leukemia
— August 2011
Crizotinib Application filed in the EU for treatment of previously
treated ALK-positive advanced non-small cell lung
cancer
— August 2011
Axitinib Application filed in Japan for treatment of advanced
renal cell carcinoma after failure of prior systemic
treatment
— July 2011
ELIQUIS
(Apixaban)(b)
Approval in the EU for prevention of venous
thromboembolism following elective hip or knee-
replacement surgery
May 2011 —
Axitinib Application filed in the EU for treatment of advanced
renal cell carcinoma after failure of prior systemic
treatment
— May 2011
Revatio Approval in the EU for pediatric PAH May 2011 —
Crizotinib Application filed in Japan for treatment of ALK-positive
advanced non-small cell lung cancer
— March 2011
Xiapex Approval in the EU for treatment of Dupuytren’s
contracture
February 2011 —
Sutent Approval in the EU for treatment of unresectable
pancreatic neuroendocrine tumor
December 2010 —
Taliglucerase alfa Application filed in the EU for treatment of Gaucher
disease
— November 2010
* For applications in the EU, the dates set forth in this column are the dates on which the European Medicines Agency (EMA) validated our
submissions.
(a) This indication for ELIQUIS (apixaban) is being developed in collaboration with BMS.
(b) This indication for ELIQUIS (apixaban) was developed and is being commercialized in collaboration with BMS.
In March 2011, we decided to withdraw our application in Japan for Toviaz for the treatment of overactive bladder due to required
stability testing. We intend to resubmit the application in the first half of 2012.
In March 2010, we withdrew our application in Japan for Prevenar 13 for the prevention of invasive pneumococcal disease in infants
and young children due to a request by the Pharmaceutical and Medical Devices Agency (PMDA) for an additional study of this
indication in Japanese subjects. We are conducting the requested additional study and, if the results are positive, we plan to
resubmit the application.
28 2011 Financial Report