February 26, 2009
 

2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China


2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China
The 2009 PDA/FDA Asia Pacific Pharmaceutical Ingredient Supply Chain Conference is jointly sponsored by PDA and the Shanghai Municipal FDA (SHFDA) as a result of a memorandum of understanding signed in September 2008.
Source: www.pda.org

BPCA/Pediatric Exclusivity Statistics
BPCA/Pediatric Exclusivity Statistics (updated)
Source: www.fda.gov

Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection)
Elan estimates availability of Azactam 1 gram vials (NDC 51479-0041-15), and 2 gram vials (NDC 51479-0042-15)in March/April time frame. For additional information call Elan at 1-800-859-8586, and Baxter has 1 gram (NDC 51479-0048-01) and 2 gram (NDC 51479-0049-01) frozen aztreonam available on allocation. For additional information call Baxter at 1-888-229-0001.
Source: www.fda.gov

Guidance for Industry
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 8: Sterility Test General Chapter
Source: www.fda.gov

Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg)
Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009.
Source: www.fda.gov

Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
See information in Related Information section.
Source: www.fda.gov

Drug Shortages: Current Drug Shortages: Calcium Disodium Versenate Injection 200 mg/mL 5 mL ampules (NDC 00089-0510-06)
Additional Information: FDA and Graceway are working to resolve the shortage as soon as possible.
Source: www.fda.gov

Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules
See Web site for additional information
Source: www.fda.gov

BPCA of 2007: List of Determinations including Written Request
Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
Source: www.fda.gov

Listing of OTC Active Ingredients
Listing of OTC Active Ingredients sorted by alphabetical and by monograph
Source: www.fda.gov

# posted by Network @ 3:58 PM

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