FDA Update: May 2011
By, Lori Clapper, Editor
FDA Approves New Diabetes Treatment
Patients with Type 2 diabetes now have another treatment option. The FDA approved Tradjenta tablets, from Boehringer Ingelheim Pharmaceuticals and Eli Lilly Co. Eight double-blind, placebo-controlled studies showed the product to be safe and effective in 3,800 adults with Type 2 diabetes. Tradjenta was studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies, such as metformin, glimepiride, and pioglitazone.
In January, the two companies struck a deal to co-develop five diabetes drugs, including Tradjenta.
Read the FDA press release.
Check out the Reuters report.
FDA, FTC Target Questionable STD Drugs
The FDA sent warning letters to several companies that market treatments that claim to treat or cure sexually transmitted diseases (STDs). The products include Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak. None have been evaluated by the FDA for safety and effectiveness and may not be introduced into interstate commerce without an FDA-approved new drug application (NDA).
Further, under the Federal Trade Commission Act, it is illegal to make unsubstantiated treatment claims. The companies have 15 days to notify the FDA of the steps they have taken to correct the violations cited in the warning letters.
Blood Thinner Recalled
Bristol-Myers Squibb recalled one lot of 1,000-count bottles of the blood thinner Coumadin. The company tested tablets from a returned bottle and found a tablet to be higher in potency than expected. The company has notified the FDA and is working to resolve the issue quickly.