A Payers’ Guide to New FDA Approvals is published annually by American Health & Drug Benefits to offer payers and other healthcare stakeholders a detailed analysis of new drugs approved by the US Food and Drug Administration (FDA) in the previous year, as well as an overview of the key drugs in the pharmaceutical pipeline. The 2014 edition represents the fifth year of publication of this Guide by American Health & Drug Benefits.
In 2013, there were 27 new molecular entities (NMEs)approved by the US Food and Drug Administration (FDA), of which more than 50% were specialty pharmaceuticals.
Drug development is fraught with significant risks for failure and astronomical expenditures, but its successes are rewarded by many lives saved and high monetary compensations. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), for every 5000 to 10,000 compounds in the pipeline, only 1 compound makes the full development route through the US Food and Drug Administration (FDA) approval process.
Abraxane (nab-Paclitaxel) Receives a New Indication for the Treatment of Patients with Metastatic Pancreatic Cancer
The American Cancer Society has estimated that approximately 45,220 new cases of pancreatic cancer would be diagnosed in the United States in 2013 and approximately 38,460 patients would die of pancreatic cancer in 2013.
Adempas (Riociguat): A Novel, First-in-Class Therapy Approved for the Treatment of 2 Types of Pulmonary Hypertension
Pulmonary hypertension is a serious and life-threatening condition that is caused by increased pressure on the pulmonary arteries. The World Health Organization (WHO) has divided pulmonary hypertension into 5 subgroups, including pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), based on the causes and treatment options.
Amitiza (Lubiprostone): The First Oral Treatment Approved by the FDA for Opioid-Induced Constipation
The opioid class of analgesic agents is sometimes used to treat pain in patients with noncancer pain, including chronic nociceptive or neuropathic pain.
Anoro Ellipta (Umeclidinium/Vilanterol): First Dual Long-Acting Inhaler for Long-Term Maintenance Treatment of COPD
hronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema, is a serious and progressive disease characterized by difficulty breathing, productive cough, shortness of breath, and chest tightness.
Overactive bladder (OAB), a condition characterized by urinary urgency, frequency, nocturia, and urgency incontinence, affects an estimated 33 million people in the United States.
Breo Ellipta (Fluticasone Furoate/Vilanterol): Fixed-Dose Combination Oral Inhaler Receives FDA Approval for Long-Term Maintenance Treatment of COPD
Chronic obstructive pulmonary disease (COPD) is a common, life-threatening disease characterized by a persistent blockage of airflow from the lungs.
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Results 1 - 10 of 33
Results 1 - 10 of 33