treatment of vulvar and vaginal atrophy.

      PENDING U.S. NEW DRUG APPLICATIONS (NDA) AND SUPPLEMENTAL FILINGS INDICATION

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE

Prevention of DVT, which may lead to PE in adult patients who have undergone hip or knee replacement surgery

Treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP)

Chronic pain

Management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time

Viviant (Bazedoxifene)(f)

* The dates set forth in this column are the dates on which the FDA accepted our submissions.

   PRODUCT

Eliquis (Apixaban)(a)

Eliquis (Apixaban)(a) Tafamidis meglumine(b)

Celebrex (Celecoxib)(d)

Remoxy (Oxycodone Hydrochloride)(e)

DATE FILED*

December 2013

July 2013 February 2012

October 2009 August 2008

August 2006

             Genotropin Mark VII Multidose Replacement of human growth hormone deficiency December 2009 Disposable Device (Somatropin

rDNA Origin)(c)

          Osteoporosis treatment and prevention

   (a) This indication for Eliquis (apixaban) was developed in collaboration with BMS.

(b) In May 2012, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted that the tafamidis meglumine data provide substantial

evidence of efficacy for a surrogate endpoint that is reasonably likely to predict a clinical benefit. In June 2012, the FDA issued a “complete response” letter with respect to the tafamidis NDA. The FDA has requested the completion of a second efficacy study, and also has asked for additional information on the data within the current tafamidis NDA. We continue to work with the FDA to define a path forward.

(c) After receiving a “complete response” letter from the FDA for the Genotropin Mark VII multidose disposable device submission, we submitted our response in August 2010. In April 2011, we received a second “complete response” letter from the FDA, and we submitted our response in July 2013. In February 2014, we received a third "complete response" letter from the FDA, and we are working with the FDA to determine next steps.

(d) In June 2010, we received a “complete response” letter from the FDA for the Celebrex chronic pain supplemental NDA. The supplemental NDA remains pending while we await the completion of the PRECISION trial, anticipated in 2015, which will inform our next steps. The PRECISION trial is designed to assess the relative long-term cardiovascular safety of Celebrex compared to prescription doses of ibuprofen and naproxen in the treatment of arthritis pain.

(e) In 2005, King entered into an agreement with Pain Therapeutics, Inc. (PT) to develop and commercialize Remoxy. In August 2008, the FDA accepted the NDA for Remoxy that had been submitted by King and PT. In December 2008, the FDA issued a “complete response” letter. In March 2009, King exercised its right under the agreement with PT to assume sole control and responsibility for the development of Remoxy. In December 2010, King resubmitted the NDA for Remoxy with the FDA. In June 2011, we and PT announced that a