New Drug Assignments and Reassignments for 2013
See drug assignments and reassignments for previous years.
(Click on a column heading to re-sort the table.)
| Drug Name |
Active Ingred |
Mfr |
Indication |
Approval Date |
AHFS Class |
NDA Chem Type* |
| Skyla® |
levonorgestrel |
Bayer |
birth control |
1/9/2013 |
68:12 - Contraceptives |
5 |
| Uceris® |
budesonide |
Santarus |
ulcerative colitis |
1/14/2013 |
68:04 - Adrenals |
5 |
| Zecuity® |
sumatriptan |
Nupathe |
migraine headache |
1/17/2013 |
28:32.28 - Selective Serotonin Agonists |
3 |
| Nesina® |
alogliptin |
Takeda |
type 2 diabetes mellitus |
1/25/2013 |
68:20.05 - DPP-4 Inhibitors |
1 |
| Oseni® |
alogliptin; pioglitazone |
Takeda |
type 2 diabetes mellitus |
1/25/2013 |
68:20.05 - DPP-4 Inhibitors; 68:20.28 - Thiazolidinediones |
1 |
| Kazano® |
alogliptin; metformin |
Takeda |
type 2 diabetes mellitus |
1/25/2013 |
68:20.05 - DPP-4 Inhibitors; 68:20.04 - Biguanides |
1 |
| Kynamro® |
mipomersen |
Genzyme |
homozygous familial hyper-cholesterolemia (HoFH) |
1/29/2013 |
24:06.92 - Antilipemic Agents, Miscellaneous |
1 |
| Ravicti® |
glycerol phenylbuterate |
Hyperion |
urea cycle disorders (UCDs) |
2/1/2013 |
40:10 - Ammonia Detoxicants |
1S |
| Delzicol® |
mesalamine |
Warner Chilcott |
ulcerative colitis |
2/1/2013 |
56:36 - Anti-inflammatory Agents |
3S |
| Versacloz® |
clozapine |
Douglas |
schizophrenia |
2/6/2013 |
28:16.08.04 - Atypical Antipsychotics |
3 |
| Pomalyst® |
pomalidomide |
Celgene |
multiple myeloma |
2/8/2013 |
10:00 - Antineoplastic Agents |
1 |
| Kadcyla® |
ado-trastuzumab emtansine |
Genentech |
metastatic HER2 breast cancer |
2/22/2013 |
10:00 - Antineoplastic Agents |
1 |
| Stivarga® |
regorafenib |
Bayer |
metastatic colorectal cancer |
2/25/2013 |
10:00 - Antineoplastic Agents |
1P |
| Osphena® |
ospemifene |
Shionogi |
menopausal dyspareunia |
2/26/2013 |
68:16.12 - Estrogen Agonists-Antagonists |
1S |
| Enskyce™ |
desogestrel; ethinyl estradiol |
Lupin |
birth control |
3/7/2013 |
68:12 - Contraceptives |
|
| Lymphoseek® |
technetium Tc99 tilmanocept |
Navidea |
lymph node mapping |
3/13/2013 |
36:68 - Roentgenography |
1S |
| Dotarem® |
gadoterate meglumine |
Guerbet |
for use in MRIs of CNS |
3/20/2013 |
36:68 - Roentgenography |
1S |
|
botulism antitoxin heptavalent (equine) |
Cangene |
botulism |
3/22/2013 |
80:04 - Serums |
1 |
| Tecfidera® |
dimethyl fumerate |
Biogen Idec |
multiple sclerosis |
3/27/2013 |
92:20 - Biologic Response Modifiers |
1 |
| Karbinal® ER |
carbinoxamine |
Tris |
seasonal and perennial allergic rhinitis; urticaria; angioedema |
3/28/2013 |
4:04 - First Generation Antihistamines |
3S |
| Jencycla™ |
norethindrone |
Lupin |
birth control |
3/28/2013 |
68:12 - Contraceptives |
|
| Quartette® |
levonorgestrel; ethinyl estradiol |
Teva |
birth control |
3/28/2013 |
68:12 - Contraceptives |
5 |
| Invokana® |
canagliflozin |
Janssen |
type 2 diabetes |
3/29/2013 |
68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors (New class) |
1 |
| Prolensa® |
bromfenac |
Bausch+Lomb |
postoperative pain and inflammation after cataract surgery |
4/5/2013 |
52:08.20 - Nonsteroidal Anti-inflammatory Agents |
5 |
| Diclegis® |
doxylamine; pyridoxine |
Duchesnay |
morning sickness |
4/9/2013 |
56:22.92 - Antiemetics, Misc |
4 |
| Daysee™ |
ethinyl estradiol; levonorgestrel |
Lupin |
birth control |
4/10/2013 |
68:12 - Contraceptives |
3 |
| Sitavig® |
acyclovir |
Bioalliance |
recurrent herpes labialis (cold sores) |
4/12/2013 |
84:04.06 - Antivirals |
3S |
| Simbrinza® |
brinzolamide; brimonidine |
Alcon |
open-angle glaucoma; ocular hypertension |
4/19/2013 |
52:40.04 - α-Adrenergic Agonists; 52:40.12 - Carbonic Anhydrase Inhibitors |
4 |
| Minastrin® 24 FE |
ethinyl estradiol; norethindrone; ferrous fumerate |
Warner Chilcott |
birth control |
4/19/2013 |
68:12 - Contraceptives |
3 |
| Pirmella™ 7/7/7 & 1/35 |
ethinyl estradiol; norethindrone |
Lupin |
birth control |
4/24/2013 |
68:12 - Contraceptives |
3 |
| Kcentra® |
prothrombin complex concentrate (human) |
CSL Behring |
urgent reversal of VKA (e.g., warfarin) in acute major bleeding episodes |
4/29/2013 |
20:28.16 - Hemostatics |
|
| Procysbi® |
cysteamine bitartrate |
Raptor |
nephropathic cystinosis |
4/30/2013 |
92:92 - Other Misc Therapeutic Agents |
5 |
| Breo Ellipta® |
fluticasone / vilanterol |
Glaxo |
COPD |
5/10/2013 |
68:04 - Adrenals; 12:12.08.12 - Selective β2-Adrenergic Agonists |
1 |
| Xofigo® |
radium (Ra223) |
Bayer |
advanced prostate cancer with metastasis to bone |
5/15/2013 |
78:00 - Radioactive Agents |
1P |
* NDA Chemical Types
| Number |
Meaning |
| 1 |
New molecular entity (NME) |
| 2 |
New ester, new salt, or other noncovalent derivative |
| 3 |
New formulation |
| 4 |
New combination |
| 5 |
New manufacturer |
| 6 |
New indication |
| 7 |
Drug already marketed, but without an approved NDA |
| 8 |
OTC (over-the-counter) switch |
AHFS Classification Changes for 2013
The following table describes changes to the AHFS Pharmacologic-Therapeutic Classification© that will go into effect with the publication of the 2013 edition of AHFS Drug Information® (February 1, 2013), as well as any new classes added after the publication of the 2012 edition. This is only a partial listing of the AHFS PTC. The full classification system, along with a list of drugs covered in AHFS DI and their corresponding classes, is available in the printed edition and is available electronically in a separate file. Please contact the ASHP Marketing and Sales Office for licensing information at 301-664-8757 or marketing@ashp.org.
| AHFS Class |
Retired |
Change Description |
28:20
|
- |
Name Change (Anorexigenic Agents and Respiratory and CNS Stimulants) |
28:20.08
|
- |
New classification (Anorexigenic Agents) |
28:20.08.04
|
- |
New classification (Amphetamine Derivatives) |
28:20.08.32
|
- |
New classification (Selective Serotonin Receptor Agonists) |
28:20.32
|
- |
New classification (Respiratory and CNS Stimulants) |
28:20.80
|
- |
New classification (Wakefulness-promoting Agents) |
28:20.92
|
- |
Name Change (Anorexigenic Agents and Stimulants, Miscellaneous) |
48:14
|
- |
New classification (Cystic Fibrosis Transmembrane Conductance Regulator Modulators) |
48:14.04
|
- |
New classification (Cystic Fibrosis Transmembrane Conductance Regulator Correctors) |
48:14.12
|
- |
New classification (Cystic Fibrosis Transmembrane Conductance Regulator Potentiators) |
68:20.18
|
- |
New classification 4/3/2013 (Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors) |
Drug Reassignments for 2013
Along with the changes to the classification system noted above, the following drugs have been assigned to new classes accordingly:
| Drug Name(s) |
Active Ingred |
Old AHFS Class |
New AHFS Class |
| Tenuate® |
diethylpropion |
28:20.92 |
28:20.08.04 |
| Adipost®, Bontril® |
phendimetrazine |
28:20.92 |
28:20.08.04 |
| Adipex®, Ionamin® |
phentermine |
28:20.92 |
28:20.08.04 |
| Belviq® |
lorcaserin |
28:20.92 |
28:20.08.32 |
| Amoply® |
ammonia spirit, aromatic |
28:20.92 |
28:20.32 |
| Cafcit®, No Doz®, Vivarin® |
caffeine/ caffeine and sodium benzoate |
28:20.92 |
28:20.32 |
| Focalin® |
dexmethylphenidate |
28:20.92 |
28:20.32 |
| Dopram® |
doxapram |
28:20.92 |
28:20.32 |
| Concerta®, Daytrana®, Metadate®, Methylin®, Ritalin® |
methylphenidate |
28:20.92 |
28:20.32 |
| Nuvigil® |
armodafinil |
28:20.92 |
28:20.80 |
| Provigil® |
modafinil |
28:20.92 |
28:20.80 |
| Kalydeco® |
ivacaftor |
48:92 |
48:14.12 |
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