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1: Generic Drugs: Information for Industry External-link Sep 08 News and Announcements updated
2: Drugs@FDA Data Files External-link Sep 08 Data files updated through September 8, 2010.
3: New and Generic Drug Approvals External-link Sep 08 Drug Approval Listing
4: Current Drug Shortages External-link Sep 08 New/Updated Drug Shortages: NeoProfen (ibuprofen lysine) Injection (updated) 9/8/2010, Etoposide solution for injection (updated) 9/7/2010, Etoposide solution for injection 9/2/2010, Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg) (updated) 9/2/2010, Mitomycin for injection (updated) 9/2/2010, Mexiletine Capsules (150mg, 200mg, and 250mg) (updated) 9/2/2010, Leucovorin Calcium Lyophilized Powder for Injection (updated) 9/2/2010, Haloperidol Decanoate Injection (updated) 9/2/2010, Furosemide Injection 10mg/ml (updated) 9/2/2010, Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34) (updated) 9/2/2010, Succinylcholine injection (updated) 9/2/2010, Atracurium injection (updated) 9/1/2010, Calcium Chloride Injection (updated) 9/1/2010, Cisplatin injection 1 mg/mL solution (updated) 9/1/2010, Dextrose 50% injection (updated) 9/1/2010, Fabrazyme (agalsidase beta) (updated) 9/1/2010, Technetium Tc99m Generators (updated)8/31/2010, Succinylcholine injection 8/25/2010, Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg) 8/20/2010, Cisplatin injection 1 mg/mL solution 8/18/2010, Technetium Tc99m Generators (updated) 8/16/2010, Naloxone Injection (updated) 8/16/2010, Vecuronium Injection (updated) 8/10/2010, Mitomycin for injection (updated) 8/10/2010, Haloperidol Decanoate Injection (updated) 8/10/2010, Furosemide Injection 10mg/ml (updated) 8/10/2010
5: Newly Added Guidance Documents External-link Sep 08
6: Pediatric Exclusivity Statistics External-link Sep 03 Updated list.
7: Safe Drug Use After a Natural Disaster External-link Sep 02 Updated
8: Information Regarding Insulin Storage and Switching Between Products in an Emergency External-link Sep 02 Updated
9: National Drug Code Directory External-link Sep 01 The National Drug Code has been updated with data through September 1, 2010.
10: FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections External-link Sep 01 [09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections.
11: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) External-link Aug 27 One new report (April to June 2010) and seven updated reports
12: September 20, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement External-link Aug 27 Advisory Committees (Drugs)
13: Warning Letters 2010 External-link Aug 25 Letters added
14: FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk External-link Aug 23 [08-20-2010] The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet).
15: FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide) External-link Aug 20 [07-13-2010] The U.S. Food and Drug Administration (FDA) is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) – a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced.
16: FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine) External-link Aug 16 [08-12-2010] The U.S. Food and Drug Administration (FDA) is informing the public that Lamictal (lamotrigine)†, a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis.
17: Additions/Deletions for Prescription and OTC Drug Product Lists External-link Aug 13 The list has been updated through May 2010.
18: Orange Book Zip File External-link Aug 13 July 2010 Orange Book data files, zip format.
19: FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen External-link Aug 11 [07-29-2010] The U.S. Food and Drug Administration (FDA) is reviewing reports of adverse effects from Evamist in children who may have been unintentionally exposed to the drug through skin contact with women using this product.
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