What's New on the FDA Drugs Site
October 6, 2016
- Final rule amending list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety or effectiveness reasons
- Drugs@FDA Data Files (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- National Drug Code Directory
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
New and Generic Drug Approvals
October 5, 2016
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Atrovent Hfa | ipratropium bromide | Aerosol, Metered;Inhalation | Boehringer Ingelheim | Manufacturing Change or Addition |
| Ceretec | technetium tc-99m exametazime kit | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Comtan | entacapone | Tablet;Oral | Orion Pharma | Manufacturing Change or Addition |
| Entocort Ec | budesonide | Capsule;Oral | Perrigo Pharma Intl | Manufacturing Change or Addition |
| Flovent Diskus 100 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Flovent Diskus 250 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Flovent Diskus 50 | fluticasone propionate | Powder;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Flovent Hfa | fluticasone propionate | Aerosol, Metered;Inhalation | Glaxo Grp Ltd | Labeling Revision |
| Loprox | ciclopirox | Suspension;Topical | Medimetriks Pharms | Manufacturing Change or Addition |
| Lunesta | eszopiclone | Tablet;Oral | Sunovion Pharms Inc | Manufacturing Change or Addition |
| Mucinex | guaifenesin | Tablet, Extended Release;Oral | Reckitt Benckiser | Manufacturing Change or Addition |
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Friday, October 7, 2016
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