Celgene issues a Dear Healthcare Professional letter for Innohep - Celgene issues a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency
DDMAC Letter - Division of Drug Marketing, Advertising, and Communications Letter: HUMIRA (adalimumab) Injection, Abbott
DDMAC Letter - Division of Drug Marketing, Advertising, and Communications Letter: Xodol ( hydrocodone bitartrate and acetaminophen) tablets
Drug Firm Annual Registration Status - Drug Firm Annual Registration Status updated. The status report now includes Data Universal Numbering System Number.
Drug Shortages: Current Drug Shortages; Cisplatin Injection 1mg/ml - APP has supplies available and is currently allocating (50 mL vial -NDC 63323-103-51, 100 mL vial -NDC 63323-103-65, and 200 mL - NDC 63323-103-64). Teva has their 50 mL vial (NDC 00703-5747-01) and 100 mL vial (NDC 00703-5748-11) on back order with expected releases in the next several weeks. Bedford has all presentations, including Novaplus presentations, on backorder with no release date.
MedWatch item on antiepileptic drugs - FDA is requiring that all manufacturers of antiepileptic drugs include a Warning in their labeling and develop a Medication Guide to be provided to patients to inform them of the risks of suicidal thoughts or actions.