New Drug Application (NDA) approval involves various steps including pre-clinical research, investigational new drug application, clinical studies, and NDA review. NDAs can be obtained for new molecules or for existing drug molecules with a new formulation or for a new indication. This column summarizes NDAs for the second quarter 2014 (April 2014 to June 2014). FDA awarded 23 NDAs in 2Q14. The key indications were in the areas of various types of cancer, cardiovascular diseases, and diabetes. The trend of using biological sources—such as human insulin, anti-hemophilic factor and radioactive molecules (eg, Technetium)— is increasing. Fourteen (60.8%) NDAs were small molecules while the remaining 9 (39.2%) were large molecules. This shows that companies are interested in developing formulations containing large molecules. In this quarter, 9 large companies (39.1%) received NDA approvals, and the remaining 15 companies (60.9%) were mid-sized and small companies. Seven drug molecules were granted the orphan drug status (30.4%). All the NDAs approved this quarter were prescription drug products. Two companies (8.7%) had applied for a combination drug therapy— Ketorolac/phenylephrine by Omeros Corporation and Buprenorphine/ naloxone by BioDelivery Sciences International, Inc.
There were cases where a company started to work on a particular drug, but drug development was taken over by a different company. Dow Pharmaceutical Sciences (DPS) initiated the work on Jublia®. In 2008, DPS was acquired by Valeant Pharmaceuticals and completed the remaining work to file the NDA. Similarly, Vazculep® development was initiated by Eclat Pharmaceuticals. Flamel Technologies took over Eclat in March 2012 and so also Vazculep®.
In March 2013, the FDA approved Lymphoseek® (technetium Tc 99m tilmanocept) injection. It was indicated for lymphatic mapping to locate lymph nodes in patients with solid tumors. It received a supplemental NDA approval for another indication in June 2014.
Unlike last quarter, the dosage forms this quarter were varied. Intranasal gel, intradermal gel, inhalation powder, and buccal films were some of the dosage forms in approved NDAs—different from the typically preferred tablets and capsules. Injections still remain the majority (almost 40%) in the approved NDAs. Cancer and cardiovascular medications are expensive, except that the pricing structure remains unpredictable.