Pfizer 2015 Annual Report Download - page 30

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Financial Review
Pfizer Inc. and Subsidiary Companies
2015 Financial Report
29
REGULATORY APPROVALS AND FILINGS IN THE EU AND JAPAN
PRODUCT DESCRIPTION OF EVENT DATE APPROVED DATE FILED*
Xalkori (Crizotinib) Application filed in the EU for the treatment of ROS1-positive
non-small cell lung cancer
February 2016
Eliquis (Apixaban)(a) Approval in Japan for the treatment and prevention of
recurrence of venous thromboembolism (deep vein thrombosis
and pulmonary embolism)
December 2015 —
Xalkori (Crizotinib) Approval in the EU for first line treatment of anaplastic
lymphoma kinase (ALK)-positive non-small cell lung cancer
November 2015 —
Effexor SR (Venlafaxine HCl) Approval in Japan for treatment of depression/depressed state September 2015 —
Ibrance (Palbociclib) Application filed in the EU for palbociclib in combination with
endocrine therapy for the treatment of hormone receptor-positive
(HR+), HER2- advanced or metastatic breast cancer, as well as
for the treatment of recurrent advanced breast cancer
— August 2015
Xeljanz (Tofacitinib) Application filed in Japan for treatment of psoriasis vulgaris and
psoriatic arthritis with inadequate response to existing therapies
— March 2015
* 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) was developed and is being commercialized in collaboration with Bristol-Myers Squibb (BMS).
LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS
FOR IN-LINE AND IN-REGISTRATION PRODUCTS
PRODUCT PROPOSED INDICATION
Bosulif (Bosutinib) First-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous
leukemia, which is being developed in collaboration with Avillion Group
Inlyta (Axitinib) Adjuvant treatment of renal cell carcinoma, which is being developed in collaboration with SFJ Pharmaceuticals
Group
Ibrance (Palbociclib) Treatment of high-risk early breast cancer, in collaboration with the German Breast Group
Ibrance (Palbociclib) Treatment of HR+ early breast cancer, in collaboration with the Alliance Foundation Trials, LLC, and the Austrian
Breast Colorectal Cancer Study Group
Lyrica (Pregabalin) Peripheral neuropathic pain
Lyrica (Pregabalin) CR (once-a-day) dosing
Sutent (Sunitinib) Adjuvant treatment of renal cell carcinoma
Tofacitinib Treatment of psoriasis (ex-US)
Tofacitinib Treatment of ulcerative colitis
Tofacitinib Treatment of psoriatic arthritis
Vyndaqel (Tafamidis meglumine) Adult symptomatic transthyretin cardiomyopathy