FDA actions in brief, December 2007
FDA-related information through December 2007 for nilotinib (Tasigna), sitagliptin (Januvia), SymlinPen120, SymlinPen60, terbinafine (Lamisil), diclofenac (Voltaren Gel), sevelamer (Renvela), brimonidine/timolol (Combigan), Zingo, Totect, Menactra, FluMist, ACAM2000, Afluria, palonosetron injection (Aloxi), bortezomib (Velcade), certuximab (Erbitux), alemtuzumab (Campath), fosamprenavir (Lexiva), and tipranavir (Aptivus)
Nilotinib (Tasigna, Novartis) was approved for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia who are resistant or intolerant to prior treatment, including imatinib.
The labeling for sitagliptin (Januvia, Merck) was updated to include the agent's use in several new regimens as an adjunct to diet and exercise for the treatment of type 2 diabetes: as initial therapy in combination with metformin; as add-on therapy to a sulfonylurea (glimepiride) when the single agent alone does not provide adequate glycemic control; and as add-on therapy to the combination of a sulfonylurea (glimepiride) and metformin when dual therapy does not provide adequate glycemic control.
Pen-injector devices (SymlinPen 120 and SymlinPen 60, Amylin) were approved for the administration of pramlintide (Symlin, Amylin), which is approved for the treatment of patients with diabetes who are treated with mealtime insulin.
An oral granule formulation of terbinafine (Lamisil, Novartis) was approved for the treatment of tinea capitis in children aged ≥4 years.
FDA approved a topical gel formulation of diclofenac (Voltaren Gel, Novartis) for the treatment of pain associated with osteoarthritis in joints amenable to topical treatment.
A new formulation of sevelamer (Renvela, Genzyme) was approved for the control of serum phosphorus in patients with chronic kidney disease who are undergoing dialysis.
FDA approved brimonidine/timolol ophthalmic solution 0.2%/0.5% (Combigan, Allergan) for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled intra-ocular pressure.
A lidocaine powder intradermal injection system (Zingo, Anesiva) was approved for topical, local analgesia to reduce the pain associated with venous access procedures in children aged 3 to 18 years.
A kit containing dexrazoxane for injection (Totect, TopoTarget) was approved for the treatment of extravasation in patients undergoing anthracycline chemotherapy.
Meningococcal (groups A, C, Y, and W-135) diphtheria toxoid conjugate vaccine (Menactra, Sanofi Pasteur) was approved for the prevention of meningococcal disease in children aged 2 to 10 years.
A nasal influenza virus vaccine (FluMist, MedImmune) was approved for the active immunization of children aged 2 to 5 years against influenza disease caused by influenza virus types A and B.
Smallpox vaccine, live (ACAM2000, Acambis) was approved for the active immunization against smallpox disease in people determined to be at high risk for smallpox infection.
An influenza virus vaccine (Afluria, CSL) was approved for the active immunization of adults aged ≥18 years against influenza disease caused by influenza virus types A and B.
The dosing recommendations for palonosetron injection (Aloxi, MGI) were changed to allow more frequent dosing for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
The labeling for bortezomib (Velcade, Millennium) was updated to allow for the administration of this agent without dose adjustments for the treatment of multiple myeloma in patients with impaired kidney function, including those requiring dialysis, who have received ≥1 prior therapy.
The labeling for cetuximab (Erbitux, ImClone/Bristol-Myers Squibb) was updated to allow for the drug's use as a single agent for the treatment of epidermal growth factor inhibitor-expressing metastatic colorectal cancer after failure of both irinotecan-and oxaliplatin-based regimens.
The labeling for alemtuzumab (Campath, Genzyme/Bayer) was updated to allow for the drug's use as a single agent for the treatment of B-cell chronic lymphocytic leukemia.
The labeling for fosamprenavir (Lexiva, GlaxoSmithKline) was updated to allow for administration of this agent with ritonavir 100 mg for the treatment of HIV infection.
The accelerated approval for tipranavir (Aptivus, Boehringer Ingelheim) was converted to a full approval. This agent is approved for combination antiretroviral treatment of patients with HIV-1 infection who are treatment experienced and infected with HIV-1 strains that are resistant to >1 protease inhibitor.