What's New on the FDA Drugs Site
August 22, 2012
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Drugs@FDA Download File (updated)
- FDA's Clinical Investigator Training Course, November 13-15, 2012. College Park, MD. This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials. Meeting information and registration
- Spanish FDA Drug Safety Communication: El uso de codeína en ciertos niños tras amigdalectomía y/o adenoidectomía puede llevar a eventos adversos poco comunes pero que pueden poner en peligro la vida o causar la muerte
August 21, 2012
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- FDA Drug Info Rounds: Patents and Exclusivity
- Paragraph IV Patent Certifications (updated)
August 20, 2012
- Office of Scientific Investigations (OSI) Metrics Overview (updated)
- Current Drug Shortages Index (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Drug Firm Annual Registration Status (updated)
- Medication Guides (updated)
- National Drug Code Directory (updated)
New and Generic Drug Approvals
August 21, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Doxycycline | doxycycline hyclate | Injectable; Injection | Pfizer | Approval |
Dulera | formoterol fumarate; mometasone furoate | Aerosol, Metered; Inhalation | Merck Sharp Dohme | Labeling Revision |
Mycophenolic Acid | mycophenolic acid | Tablet, Delayed Release; Oral | Apotex Inc | Approval |
Veramyst | fluticasone furoate | Spray, Metered; Nasal | Glaxosmithkline | Efficacy Supplement with Clinical Data to Support |
August 20, 2012
Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
---|---|---|---|---|
Combivent | albuterol sulfate; ipratropium bromide | Aerosol, Metered; Inhalation | Boehringer Ingelheim | Labeling Revision |
Epi E Z Pen Jr | epinephrine | Injectable; Intramuscular | Meridian Medcl Techn | Labeling Revision |
Epipen | epinephrine | Injectable; Intramuscular | Meridian Medcl Techn | Labeling Revision |
Epipen E Z Pen | epinephrine | Injectable; Intramuscular | Meridian Medcl Techn | Labeling Revision |
Epipen Jr. | epinephrine | Injectable; Intramuscular | Meridian Medcl Techn | Labeling Revision |
Ziprasidone Hydrochloride | ziprasidone hydrochloride | Capsule; Oral | Wockhardt Ltd | Tentative Approval |