Analysis Of Recent Drug Reviews Illuminates Path For Future NDAs
Every month, F-D-C Reports' Pharmaceutical Approvals Monthly dissects a new drug review by FDA. Using FDA's own review documents, including the discipline reviews, decision memos, meeting minutes, e-mails, and other documents, the publication strives to illuminate the agency decision-making process.
You may also be interested in...
FDA approval of Genentech's Avastin for first-line treatment of metastatic breast cancer may trigger the first significant trial of the biotech's Avastin patient assistance program, which caps annual drug expenditures at $55,000 for approved indications but has not seen much utilization by colorectal or non-small cell lung cancer patients
GlaxoSmithKline is pricing its breast cancer therapy Tykerb at a slight discount to Genentech's Herceptin (trastuzumab) in the metastatic breast cancer setting
Shire will seek to transition patients from Adderall XR to its next-generation attention deficit/hyperactivity disorder drug Vyvanse prior to 2009, when Adderall XR generics are expected to launch