What's New on the FDA Drugs Site
February 3, 2014
- Current
Drug Shortages Index (updated)
- Drugs
to be Discontinued: Calcitriol Injection
- Resolved
Drug Shortages: Hydromorphone Hydrochloride Tablets
- Resolved
Drug Shortages: Isoniazid; Rifampin (Rifamate) Capsules
- Resolved
Drug Shortages: Levothyroxine sodium (Levoxyl) Tablets
- Drug
Firm Annual Registration Status (updated)
- Drug
Firm Annual Registration Status Download File (updated)
- FDA
approves Hetlioz (tasimelteon): first treatment for non-24 hour sleep-wake
disorder in blind individuals
- National
Drug Code Directory
January 31, 2014
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
corticorelin ovine triflutate
|
Injectable;Injection
|
Ferring
|
Manufacturing Change or Addition
|
|
atazanavir sulfate
|
Capsule; Oral
|
Aurobindo Pharma Ltd
|
Tentative Approval
|
|
fexofenadine hydrochloride
|
Tablet, Orally Disintegrating;Oral
|
Sanofi Aventis Us
|
Manufacturing Change or Addition
|
|
fexofenadine hydrochloride
|
Tablet, Orally Disintegrating;Oral
|
Sanofi Aventis Us
|
Manufacturing Change or Addition
|
|
metformin hydrochloride
|
Tablet, Extended Release;Oral
|
Bristol Myers Squibb
|
Manufacturing Change or Addition
|
|
tasimelteon
|
Capsule; Oral
|
Vanda Pharmaceuticals Inc
|
Approval
|
|
insulin lispro recombinant
|
Injectable;Injection
|
Lilly
|
Manufacturing Change or Addition
|
|
insulin lispro recombinant
|
Injectable;Injection
|
Lilly
|
Manufacturing Change or Addition
|
|
insulin lispro recombinant
|
Injectable;Injection
|
Lilly
|
Manufacturing Change or Addition
|
|
carfilzomib
|
Powder;Intravenous
|
Onyx Pharms
|
Manufacturing Change or Addition
|
|
ambrisentan
|
Tablet;Oral
|
Gilead
|
Labeling Revision
|
|
oxycodone hydrochloride
|
Tablet, Extended Release;Oral
|
Purdue Pharma Lp
|
Manufacturing Change or Addition
|
|
finasteride
|
Tablet;Oral
|
Merck
|
Labeling Revision
|
|
urea, c-14
|
Capsule;Oral
|
Avent
|
Manufacturing Change or Addition
|
|
urea, c-14
|
Capsule;Oral
|
Avent
|
Manufacturing Change or Addition
|
|
sildenafil citrate
|
Tablet;Oral
|
Pfizer
|
Efficacy Supplement with Clinical Data to Support
|
|
sildenafil citrate
|
Tablet;Oral
|
Pfizer
|
Labeling Revision
|
|
sildenafil citrate
|
Solution;Intravenous
|
Pfizer
|
Efficacy Supplement with Clinical Data to Support
|
|
sildenafil citrate
|
Solution;Intravenous
|
Pfizer
|
Labeling Revision
|
|
sildenafil citrate
|
For Suspension;Oral
|
Pfizer
|
Efficacy Supplement with Clinical Data to Support
|
|
sildenafil citrate
|
For Suspension;Oral
|
Pfizer
|
Labeling Revision
|
|
menthol; methyl salicylate
|
Patch;Topical
|
Hisamitsu Pharm Co
|
Manufacturing Change or Addition
|
|
articaine hydrochloride; epinephrine bitartrate
|
Injectable;Injection
|
Deproco
|
Manufacturing Change or Addition
|
|
ciclesonide
|
Aerosol, Metered;Nasal
|
Takeda Gmbh
|
Manufacturing Change or Addition
|
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