January 1, 2014 to March 31, 2014
Receiving an approval for a New Drug Application (NDA) is something special for every pharmaceutical company. NDAs can be obtained for new molecules or for existing drug molecules with a new formulation or for a new indication. In this column, we will be summarizing NDAs for a particular quarter. In this particular column, we have put together a review of NDAs receiving approval from January 2014 to March 2014. The accompanied table lists key information on the NDAs approved. FDA awarded 25 NDAs in 1Q14, out of which 9 were for new molecules and 16 were for old molecules (36% new versus 64% old but with new indication or dosage form). Many companies are investing time and energy on large molecules. In this quarter, 20% of large molecules received NDA approval (5 out of 25). Ten drug molecules were granted the Orphan Drug status (40%).
While there has been an increased discussion on combination drug therapy, this quarter saw only 12% of NDAs (3 out of 25) with a combination dosage form granted approval. Most of the dosage forms contained single drug entity (88%). Almost all were prescription drug products (except for Aleve PM). Most of the NDAs approved were for mid- to large-size pharmaceutical companies. Bristol-Myers Squibb purchased Amylin Pharmaceuticals and thus, received 4 NDAs in 1 quarter. Tablets and capsules are still the preferred dosage forms. Nearly one-third of all the approved NDAs were injections. Companies focused on the following main indications: pain, diabetes, cancer, cardiovascular disorders, and infections. The prices for most of the products were obtained from internet research. The pricing structure of pharmaceutical products is complicated and these prices should be considered with caution. Some prices were not available.
Some additional observations of note: For 2 NDAs, 2 companies applied jointly (Eliquis and Nexium). We have to see if this becomes a trend in the future. Six NDAs each were observed in January and February, whereas in March, 13 NDAs were approved. No particular trend was observed in the selection of the trade names and in the first letter in the trade name. The trade names were 5 to 9 letters long.