In accordance with section 505A(k)(1) of the Act (Best Pharmaceuticals for Children Act of 2007 (BPCA)) and section 505B(h)(1) of the Act (Pediatric Research Equity Act of 2007 (PREA)), as amended by FDAAA (Pub. L. No. 110-85), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
Drug |
Sponsor |
Reviews |
BPCA or PREA |
Abacavir - Ziagen |
GlaxoSmithKline |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Abatacept - Orencia |
Novartis Pharmaceuticals Corp. |
Medical [note for vision impaired users] |
Clinical pharmacology [note for vision impaired users] |
Statistical [note for vision impaired users] |
PREA |
Adalimumab - Humira |
Abbot |
Medical [note for vision impaired users] |
Clinical pharmacology [note for vision impaired users] |
Statistical [note for vision impaired users] |
PREA |
Adapalene - Epiduo |
Galderma Laboratories LP |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Adefovir - Hepsera |
Gilead Sciences Inc |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Albuterol sulfate HFA - Ventolin HFA |
GlaxoSmithKline |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Amoxicillin/APC -111 - Moxatag |
MiddleBrook Pharmaceuticals |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Anastrozole - Arimidex |
AstraZeneca |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology [note for vision impaired users] |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Argatroban - Argatroban |
ENCYSIVE Pharmaceuticals Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Aripiprazole - Abilify |
Otsuka Pharmaceutical Company |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Atazanavir - Reyataz |
Bristol-Myers Squibb Company |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Azithromycin - Zmax |
Pfizer |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Bicalutamide - Casodex |
AstraZeneca Pharmaceuticals |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Brimonidine tartrate - Timolol maleate - Combigan |
Allergen, Inc. |
Medical [note for vision impaired users] |
Clinical pharmacology [note for vision impaired users] |
Statistical [note for vision impaired users] |
PREA |
Caspofungin acetate - Cancidas |
Merck |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Ciclesonide - Alvesco |
Aventis |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Ciclesonide - Omnaris |
NYCOMED |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Clindamycin Phosphate/Benzoyl Peroxide -Acanya Gel |
Dow Pharmaceutical Sciences, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Darunavir - Prezista |
Tibotec |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
BPCA |
Desmopressin acetate - Minirin |
Ferring Pharmaceuticals Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Didanosine - Videx EC |
Bristol-Myers Squibb Company |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Divalproex - Depakote ER |
Abbott |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif)
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif)
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
BPCA |
Divalproex - Depakote Sprinkle |
Abbott |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
BPCA |
Eplerenone - Inspra |
GD Searle LLC |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Esomeprazole magnesium - Nexium |
AstraZeneca |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Ezetimbe/simvastatin - Vytorin |
Merck Schering-Plough Singapore Co., LLC |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Ezetimbe - Zetia |
Merck Schering Plough Singapore
Co., LLC |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Fluocinolone acetonide - Derma-Smoothe/FS |
Hill Dermaceuticals, Inc |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Helioblock SX - Anthelios 40 |
L’Oreal USA |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Insulin Aspart - NovoLog |
Novo Nordisk, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Insulin glulisine - Apidra |
Sanofi-Aventis |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Lansoprazole Oral Suspension - Prevacid |
TAP Pharmaceutical Products |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Levetiracetam - Keppra |
UCB, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Levocetirizine dihydrochloride - Xyzal |
UCB Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Lidocaine hydrochloride - Akten |
Akorn, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Lopinavir/ritonavir - Kaletra |
Abbott |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
BPCA |
Mometasone furoate - Asmanex Twisthaler |
Schering Plough Corporation |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif)
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Nevirapine - Viramune |
Boehringer Ingelheim |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Olopatadine hydrochloride - Patanase |
Alcon Research, Ltd. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Omeprazole magnesium - Prilosec |
AstraZeneca LLP |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Peginterferon - PegIntro |
Schering-Plough Research Institute |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Phentolamine - OraVerse |
Novalar Pharmaceuticals, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Rabeprazole sodium -
Aciphex |
Eisai Medical Research Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Rocuronium bromide - Zemuron |
Organon USA, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
BPCA |
Somatropin - Accretropin |
Cangene Corporation |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Sterile Intraocular - Navstel Intraocular Irrigating Solution |
Alcon, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Technetium Tc99m - Sestamibi |
Bristol Myers Squibb |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Terbinafine - Lamisil |
Novartis Pharmaceuticals Corp. |
Medical [note for vision impaired users] |
Clinical pharmacology [note for vision impaired users] |
Statistical [note for vision impaired users] |
BPCA |
Tipranavir - Aptivus |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Topiramate - Topamax |
Johnson and Johnson Pharmaceutical
Research & Development L.L.C. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
BPCA |
Triamcinolone acetonide - Triesence |
Alcon, Inc. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Triamcinolone acetonide - Nasacort AQ |
Sanofi Aventis |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |
Valacyclovir hydrochloride - Valtrex |
GlaxoSmithKline |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif)
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
BPCA |
Valsartan - Diovan |
Novartis |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Zidovudine, ZDV - Retrovir |
GlaxoSmithKline |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
None |
PREA |
Zoledronic acid - Zometa |
Novartis Pharmaceutical Corp. |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
BPCA |
Zolmitriptan - Zomig ![New!!](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/new.gif) |
AstraZeneca |
Medical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Clinical pharmacology ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
Statistical ![PDF document](https://webarchive.library.unt.edu/eot2008/20090511182107im_/http://www.fda.gov/cder/graphics/pdf.gif) |
PREA |