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

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

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New and Generic Drug Approvals
January 31, 2014

Drug Name	Active Ingredient	Dosage Form/Route	Sponsor	Submission Type
Acthrel	corticorelin ovine triflutate	Injectable;Injection	Ferring	Manufacturing Change or Addition
Atazanavir Sulfate	atazanavir sulfate	Capsule; Oral	Aurobindo Pharma Ltd	Tentative Approval
Children's Allegra Allergy	fexofenadine hydrochloride	Tablet, Orally Disintegrating;Oral	Sanofi Aventis Us	Manufacturing Change or Addition
Children's Allegra Hives	fexofenadine hydrochloride	Tablet, Orally Disintegrating;Oral	Sanofi Aventis Us	Manufacturing Change or Addition
Glucophage Xr	metformin hydrochloride	Tablet, Extended Release;Oral	Bristol Myers Squibb	Manufacturing Change or Addition
Hetlioz	tasimelteon	Capsule; Oral	Vanda Pharmaceuticals Inc	Approval
Humalog	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Kwikpen	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Humalog Pen	insulin lispro recombinant	Injectable;Injection	Lilly	Manufacturing Change or Addition
Kyprolis	carfilzomib	Powder;Intravenous	Onyx Pharms	Manufacturing Change or Addition
Letairis	ambrisentan	Tablet;Oral	Gilead	Labeling Revision
Oxycontin	oxycodone hydrochloride	Tablet, Extended Release;Oral	Purdue Pharma Lp	Manufacturing Change or Addition
Propecia	finasteride	Tablet;Oral	Merck	Labeling Revision
Pytest	urea, c-14	Capsule;Oral	Avent	Manufacturing Change or Addition
Pytest Kit	urea, c-14	Capsule;Oral	Avent	Manufacturing Change or Addition
Revatio	sildenafil citrate	Tablet;Oral	Pfizer	Efficacy Supplement with Clinical Data to Support
Revatio	sildenafil citrate	Tablet;Oral	Pfizer	Labeling Revision
Revatio	sildenafil citrate	Solution;Intravenous	Pfizer	Efficacy Supplement with Clinical Data to Support
Revatio	sildenafil citrate	Solution;Intravenous	Pfizer	Labeling Revision
Revatio	sildenafil citrate	For Suspension;Oral	Pfizer	Efficacy Supplement with Clinical Data to Support
Revatio	sildenafil citrate	For Suspension;Oral	Pfizer	Labeling Revision
Salonpas	menthol; methyl salicylate	Patch;Topical	Hisamitsu Pharm Co	Manufacturing Change or Addition
Septocaine	articaine hydrochloride; epinephrine bitartrate	Injectable;Injection	Deproco	Manufacturing Change or Addition
Zetonna	ciclesonide	Aerosol, Metered;Nasal	Takeda Gmbh	Manufacturing Change or Addition

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