global research and development function and will accelerate our current strategies to improve innovation and overall productivity by prioritizing areas with the greatest scientific and commercial promise, utilizing appropriate risk/return profiles and focusing on areas with the highest potential to deliver value in the near term and over time (see the “Our Strategy” section of this Financial Review). Our high-priority therapeutic areas are immunology and inflammation, oncology, cardiovascular and metabolic diseases, neuroscience and pain, and vaccines.

Below are significant regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan as well as new drug candidates and additional indications in late-stage development:

  Recent FDA approvals:

  PRODUCT INDICATION DATE APPROVED

   Prevnar 13 Infant Prevention of invasive pneumococcal disease in infants and young children February 2010

  Pending U.S. new drug applications (NDA) and supplemental filings:

  PRODUCT INDICATION DATE SUBMITTED

   tafamidis meglumine Treatment of transthyretin amyloid polyneuropathy (ATTR-PN) February 2011

   Prevnar 13 Adult Prevention of pneumococcal disease in adults 50 years of age and older December 2010

   Taliglucerase alfa Treatment of Gaucher disease December 2009

   Sutent Pancreatic neuroendocrine tumor December 2009

   Genotropin Adult growth hormone deficiency (Mark VII multidose disposable device) October 2009

   Celebrex Chronic pain August 2009

   Geodon Treatment of bipolar disorder––pediatric filing October 2008

   Spiriva Respimat device for chronic obstructive pulmonary disease November 2007

   Zmax Treatment of bacterial infections––sustained release––acute otitis media (AOM) November 2006 and sinusitis––pediatric filing

   Viviant Osteoporosis treatment and prevention June 2006

   Pristiq Vasomotor symptoms of menopause June 2006

   Vfend Treatment of fungal infections––pediatric filing June 2005

 On October 6, 2010, we completed the acquisition of FoldRx. Its lead product candidate, tafamidis meglumine (Tafamidis), is in registration in both the U.S. and the EU as a first-in-class oral therapy for the treatment of transthyretin amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic neurodegenerative disease, for which liver transplant is the only treatment option currently available. Tafamidis has orphan drug designation in both the U.S. and EU and fast-track designation in the U.S.

In November 2009, we entered into a license and supply agreement with Protalix BioTherapeutics (Protalix), which provides us exclusive worldwide rights, except in Israel, to develop and commercialize taliglucerase alfa for the treatment of Gaucher disease. In April 2010, Protalix completed a rolling NDA with the FDA for taliglucerase alfa. Taliglucerase alfa was granted orphan drug designation in the U.S. in September 2009. In February 2011, Protalix received a “complete response” letter from the FDA for the taliglucerase alfa NDA that set forth additional requirements for approval. Protalix will work with the FDA to determine next steps.

In May 2010, the FDA issued a “complete response” letter