This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.
|
Sections Modified |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Avelox I.V. (moxifloxacin hydrochloride in sodium chloride injection) |  | - | | | - | - | - | - |
| Cipro I.V. (ciprofloxacin) for Intravenous Infusion | | - | | | - | - | - | - |
| Cipro (ciprofloxacin hydrochloride) Tablets | | - | | | - | - | - | - |
| Cipro (ciprofloxacin) Oral Suspension | | - | | | - | - | - | - |
| Cipro XR (ciprofloxacin extended-release tablets) | | - | | | - | - | - | - |
| Factive (gemifloxacin mesylate) Tablets | | - | | | | - | - | - |
| Floxin (ofloxacin) Tablets | | - | | | - | - | - | - |
| Levaquin (levofloxacin) Injection, for Intravenous Use | | - | | | - | - | - | - |
| Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use | | - | | | - | - | - | - |
| Noroxin (norfloxacin) Tablets | | - | | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Ontak (denileukin difttox) Solution for Intravenous Use | | - | | | | - | - | - |
| Raptiva (efalizumab) for Injection, Subcutaneous | | - | | | | | - | - |
| Regranex (becaplermin) Gel 0.01 % | | - | | - | - | - | - | - |
| Apidra (insulin glulisine [rDNA origin] injection) Solution for Injection | - | | | | | | - | - |
| Norditropin Cartridges [somatropin (rDNA origin) injection], for Subcutaneous Use | - | | | | | | - | - |
| (lansoprazole delayed-release 15 mg capsules and naproxen 500 mg tablets kit) | - | | | | | - | - | - |
| Prezista (darunavir) Tablets | - | | | | | | - | - |
| Rozerem (ramelteon) Tablets | - | | | | | - | - | - |
| Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate, USP) Tablets | - | | | | | - | - | - |
| Zomig (zolmitriptan) Nasal Spray | - | | | | | | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Arixtra (fondaparinux sodium) Injection | - | - | | | | - | - | - |
| Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets | - | - | | | | | - | - |
| Avandia (rosiglitazone maleate) Tablets | - | - | | | - | - | - | - |
| Clolar (clofarabine) Injection for Intravenous Use | - | - | | | | - | - | - |
| Cordarone (amiodarone HCl) Tablets | - | - | | | | - | - | - |
| Exjade (deferasirox) Tablets for Oral Suspension | - | - | | | - | | - | - |
| Ortho Evra (norelgestromin / ethinyl estradiol transdermal system) | - | - | | - | - | - | - | - |
| Pamidronate Disodium (pamidronate disodium injection) Solution for Intravenous Infusion | - | - | | | | - | - | - |
| Pamidronate Disodium (pamidronate disodium injection) Powder, Lyophilized, for Solution for Intravenous Infusion | - | - | | | | - | - | - |
| Precedex (dexmedetomidine hydrochloride) Injection for Intravenous Infusion [following dilution] | - | - | | | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Sutent (sunitinib malate) Capsules | - | - | | | | - | - | - |
| Treanda (bendamustine hydrochloride) for Injection, for Intravenous Infusion | - | - | | | | - | - | - |
| Atrovent (ipratropium bromide) Nasal Spray, Metered | - | - | - | | - | - | - | - |
| Cefazolin for Injection USP and Dextrose Injection USP | - | - | - | | - | - | - | - |
| Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution) | - | - | - | | - | - | - | - |
| Diabinese (chlorpropamide) Tablets, USP | - | - | - | | - | - | - | - |
| Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules | - | - | - | | - | - | - | - |
| Fosrenol (lanthanum carbonate) Chewable Tablets | - | - | - | | - | - | - | - |
| Glucotrol (glipizide) Tablets | - | - | - | | - | - | - | - |
| Glucotrol XL (glipizide) Extended Release Tablets | - | - | - | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Glynase PresTab (micronized glyburide tablets) | - | - | - | | - | - | - | - |
| Hylenex recombinant (hyaluronidase human injection) | - | - | - | | - | - | - | - |
| Kaletra (lopinavir and ritonavir) Tablet, Film Coated for Oral Use | - | - | - | | - | - | - | - |
| Kaletra (lopinavir and ritonavir) Solution for Oral Use | - | - | - | | - | - | - | - |
| Micronase (glyburide tablets, USP) | - | - | - | | - | - | - | - |
| Norvir (ritonavir) Capsules and Solution | - | - | - | | - | - | - | - |
| Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets | - | - | - | | - | - | - | - |
| Prevacid (lansoprazole) Delayed-Release Capsules | - | - | - | | - | - | - | - |
| Prevacid (lansoprazole) For Delayed-Release Oral Suspension | - | - | - | | - | - | - | - |
| Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets | - | - | - | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Riomet (metformin hydrochloride oral solution) | - | - | - | | - | - | - | - |
| Skelaxin (metaxalone) Tablets | - | - | - | | - | - | - | - |
| Tenoretic (atenolol and chlorthalidone) Tablets | - | - | - | | - | - | - | - |
| Theophylline in 5% Dextrose Injections USP | - | - | - | | - | - | - | - |
| Theophylline in 5% Dextrose Injection (theophylline injection, solution) USP, in Flexible Plastic Container | - | - | - | | - | - | - | - |
| Theophylline in Dextrose (theophylline anhydrous injection, solution) USP, in VIAFLEX Plus Container | - | - | - | | - | - | - | - |
| Tobi (tobramycin inhalation solution, USP) Nebulizer Solution - For Inhalation Use Only | - | - | - | | - | - | - | - |
| Trusopt (dorzolamide hydrochloride ophthalmic solution) | - | - | - | | - | - | - | - |
| Janumet (sitagliptin and metformin hydrochloride) Tablets | - | - | - | - | | - | - | - |
| Januvia (sitagliptin) Tablets | - | - | - | - | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Lexapro (escitalopram oxalate) Tablets and Oral Solution | - | - | - | - | | - | - | - |
| Myambutol (ethambutol hydrochloride) Tablets | - | - | - | - | | - | - | - |
| Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets | - | - | - | - | - | - | - | - |
| Requip XL (ropinirole extended-release tablets) | - | - | - | - | - | | - | - |
