May 12, 2009
 

Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated)


Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated)
Current Drug Shortages: Cisplatin Injection 1mg/ml : See updated Related Information Section for Teva
Source: www.fda.gov

Guidance for Industry
Individual Product Bioequivalence Recommendations
Source: www.fda.gov

Efalizumab (marketed as Raptiva) Information
Efalizumab (marketed as Raptiva) Information
Source: www.fda.gov

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conductedf under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
Source: www.fda.gov

Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
Source: www.fda.gov

Drug Shortages: Current Drug Shortages: Metoprolol succinate extended release tablets (updated)
Current Drug Shortages: Metoprolol succinate extended release tablets: See updated letter in Related Information Section
Source: www.fda.gov

FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic and Myobloc
FDA updates the Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
Source: www.fda.gov

Guidance for Industry
Submission of Summary Bioequivalence Data for ANDAs
Source: www.fda.gov

Paragraph IV Patent Certifications
Office of Generic Drugs: Paragraph IV Patent Certifications (updated)
Source: www.fda.gov

Subscribe to Posts [Atom]