Table 2. Characteristics and Approval Timing of New Formulations of Novel Tablet or Capsule Drugs Approved by the US Food and Drug Administration, 1995-2010 (N = 206).

Characteristics and timing of new formulations and generics	No. (%)
No. of new formulations per novel drug
0	125 (60.7)
1	45 (21.8)
2	23 (11.2)
≥3	13 (6.3)
New formulations and generics of novel drugs
With ≥1 new formulation	81 (39.3)
With ≥1 generic	167 (81.1)
With 0 new formulations and 0 generics	23 (11.2)
With ≥1 new formulation and 1 generic	65 (31.6)
First new formulation type (n = 81)
Dosage forma	34 (41.9)
Combination	29 (35.8)
Indication	13 (16.0)
Other	5 (6.2)
Approval timing of novel drug, new formulation, and generic, median (IQR), y
Novel drug and first new formulation approval	4.6 (2.3-8.6)
Novel drug and first generic approval	11.4 (8.1-14.5)
First new formulation approval and first generic approval	5.9 (1.5-10.9)

^a Carvedilol had a new formulation that was both a switch from tablet to extended-release capsule (ie, a new dosage form) and approved as carvedilol phosphate (ie, a new active ingredient). This drug was included in the sample as a new dosage form.