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SECTION TITLE


Figure 6. List of NDAs approved for various medical conditions in 2015


which NDA approval were received for the very first time are listed in Table 1.


Conclusion


This review summarizes various trends observed for approved NDAs in 2015. It will be important to conduct such an analysis every year to understand year-to-year trends. Liquid products were the most popular dosage form in 2015. The key trend was – a remarkable interest in large molecules as monoclonal antibodies for cancer and blood related disorder. It is interesting to note that some new companies are in the list to obtain more than three NDAs approved. Products for cancer, cardiac disorder and blood related disorder contributed major numbers in NDAs approval.


References


1. Horizon Lines: A Yearly Review of NDAs – 2014, Harshada Sant, Rucha Kelkar and Hemant Joshi, Pharmaceutical Outsourcing, July-August, Volume 16, Issue 4, 2015, www. pharmoutsourcing.com.


15% of the total NDAs were for the management of CNS disorder. A considerable amount of NDAs was approved for other major disease conditions like blood related disorders, cardiac disorders and infectious diseases. Blood related disorders include anemia, hemostasis, thromboembolism, deep vein thrombosis, chronic iron overload, hemophilia etc. Ischemic stroke prophylaxis, management of chronic heart failure, high cholesterol, hypertension, acute coronary syndrome etc., were classified as cardiac disorders. Infectious diseases include viral, bacterial and fungal infections.


Cancer, blood-related disorders, CNS disorders, infectious diseases and cardiac disorders were the top five diseases for which NDA approvals were received.


There were few NDAs, which were approved for the first time for a particular disease. Drug molecules for novel medical conditions for


2. A review of NDAs : January – February, 2015, Harshada Sant and Hemant Joshi, Pharmaceutical Outsourcing, September-October, Volume 16, Issue 5, 2015, www. pharmoutsourcing.com.


3. Horizon Lines: A Review of NDAs – March – April, 2015, Sonal Pathak, Harshada Sant and Hemant Joshi, Pharmaceutical Outsourcing, November-December, Volume 16, Issue 7, 2015, www.pharmoutsourcing.com.


4. Horizon Lines: A Quarterly Review of NDAs – May - July, 2015, Sonal Pathak, Harshada Sant and Hemant Joshi, Pharmaceutical Outsourcing, January-February issue, Volume 17, Issue 1 2016, www.pharmoutsourcing.com.


5. Horizon Lines: A Quarterly Review of NDAs – 3Q15, 2015, Sonal Pathak, Harshada Sant and Hemant Joshi, Pharmaceutical Outsourcing, March-April, Volume 17, Issue 2, 2016, www. pharmoutsourcing.com.


6. Horizon Lines: A Quarterly Review of NDAs – 4Q15, 2015, Sonal Pathak, Harshada Sant and Hemant Joshi, Pharmaceutical Outsourcing, May-June, Volume 17, Issue 3, 2016, www. pharmoutsourcing.com


7. Food and Drug Administration, www.fda.gov. Drug name Deoxycholic acid (Injection) Eluxadoline (Tablet) Dichlorphenamide (Tablet) Company


Table 1. Some unique NDAs approved in 2015 Disease condition


Kythera Biopharmaceuticals, Inc. Actavis Plc.


Taro Pharmaceutical Industries Ltd.


Interferon beta-1b (SC Injection) Bayer Healthcare Ledipasvir and Sofosbuvir (Tablet) Gilead Sciences Inc. Naloxone (Nasal spray)


Adapt Pharma Inc. Sebelipase alfa (Injection)


Von willebrand factor (recombinant) (Injection)


Alexion Pharmaceuticals, Inc. Baxalta Incorporated


Submental Fullness (double chin)


Irritable Bowel Syndrome with diarrhea


Primary Hyperkalemic and Hypokalemic Periodic Paralysis


Relapsing Multiple Sclerosis Chronic Hepatitis C


Opioid Overdose Lysosomal Acid Lipase Deficiency Von Willebrand's Disease


Comment


First and only approved non-surgical treatment for treatment of double chin


First in class treatment First medicine approved by FDA for primary period paralysis First and only electronic auto injector First and only single tablet regimen for treatment of HCV


This is the first FDA-approved nasal spray version of naloxone hydrochloride


First treatment available for the rare disease


Vonvendi is the first FDA-approved recombinant von Willebrand factor


pharmoutsourcing.com | 41 | July/August 2016


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