Tuesday, February 4, 2014

Drug Manufacturing Shortages within the U.S. February 2014.


FDA (U.S. Food and Drug Administration)
What's New on the FDA Drugs Site
February 3, 2014

New and Generic Drug Approvals
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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