FDA Actions in Brief January 2013

January 31, 2013

Recent FDA Approvals (through January 2013) related to (Deferasirox, Exjade, Novartis, bevacizumab, Avastin, Roche Group, trivalent influenza vaccine, Flublok, Protein Sciences, Budesonide, Uceris, Santarus, pooled plasma blood product, Octaplas, Octapharma, Sumatriptan iontophoretic transdermal system, Zecuity, NuPathe, onabotulinumtoxinA, Botox, Allergan

Deferasirox (Exjade, Novartis) was approved to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).

A new indication for bevacizumab (Avastin, Genentech, a member of the Roche Group) was approved in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan or oxaliplatin containing chemotherapy after their cancer worsens (second-line treatment).

The first trivalent influenza vaccine (Flublok, Protein Sciences) was approved made using an insect virus (baculovirus) expression system and recombinant DNA technology for the prevention of seasonal influenza disease in people aged 18 to 49 years.

Budesonide (Uceris, Santarus and Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals SpA) extended-release tablets were approved for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Pooled plasma blood product (Octaplas, Octapharma) was approved for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficent levels.

Sumatriptan iontophoretic transdermal system (Zecuity, NuPathe) was approved for the acute treatment of migraine with or without aura in adults. It also provides relief of both migraine headache pain and migraine-related nausea.

FDA expanded the approved use onabotulinumtoxinA (Botox, Allergan) to treat adults with overactive bladder (OAB) who cannot use or do not adequately respond to anticholinergics.