FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA
Brand Name |
Generic Name |
Manufacturer |
Adult Approval Date |
Pediatric Approval Date |
---|---|---|---|---|
Agenerase |
amprenavir |
GlaxoSmithKline |
15-Apr-99 |
15-Apr-99 |
Combivir |
zidovudine and lamivudine |
GlaxoSmithKline |
26-Sep-97 |
no pediatric labeling* |
Crixivan |
indinavir |
Merck |
13-Mar-96 |
no pediatric labeling* |
Epivir |
lamivudine, 3TC |
GlaxoSmithKline |
17-Nov-95 |
17-Nov-95 |
Fortovase |
saquinavir |
Roche |
7-Nov-97 |
no pediatric labeling* |
Hivid |
zalcitabine, ddC |
Roche |
19-Jun-92 |
no pediatric labeling* |
Invirase |
saquinavir |
Roche |
6-Dec-95 |
no pediatric labeling* |
Kaletra |
lopinavir, ritonavir |
Abbott Laboratories |
15-Sep-00 |
15-Sep-00 |
Norvir |
ritonavir |
Abbott Laboratories |
1-Mar-96 |
14-Mar-97 |
Rescriptor |
delavirdine |
Pfizer |
4-Apr-97 |
no pediatric labeling* |
Retrovir |
zidovudine, AZT, ZDU |
GlaxoSmithKline |
19-Mar-87 |
1-May-90 |
Sustiva |
efavirenz |
Bristol Myers-Squibb |
21-Sep-98 |
21-Sep-98 |
Videx |
didanosine, ddI |
Bristol Myers-Squibb |
9-Oct-91 |
9-Oct-91 |
Viracept |
nelfinavir |
Agouron Pharmaceuticals |
14-Mar-97 |
14-Mar-97 |
Viramune |
nevirapine |
Boehringer Ingelheim |
21-Jun-96 |
11-Sep-98 |
Viread |
tenofovir disoproxil fumarate |
Gilead |
26-Oct-01 |
no pediatric labeling* |
Zerit |
stavudine, d4T |
Bristol Myers-Squibb |
24-Jun-94 |
6-Sep-96 |
Ziagen |
abacavir |
GlaxoSmithKline |
17-Dec-98 |
17-Dec-98 |
* "While some of these drugs may, in practice, be used in the treatment of children of various ages, the sponsors have not submitted data to support a labeled pediatric indication at this time."