Recently, AVACEN 100, Class-IIa, OTC medical device has acquired the CE (Conformité Européenne) Mark approval to treat widespread pain concerned with fibromyalgia which was announced by AVACEN Medical. The CE Mark permits AVACEN to market the AVACEN 100 to the European Union's 28 member countries where many prescription drugs, available in the U.S., have been rejected by regulatory officials for managing fibromyalgia pain.
The Food and Drug Administration declared that it would require strong new warnings that the combined use of opioid medications and benzodiazepines, a class of anti-anxiety medications can dangerously suppress breathing and cause coma or death. Thus, the stronger warning is required just to ensure the public that the combination can be dangerous.
FDA announced that the safety labeling changes (SLC) program will be managed by the Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM). OCOMM has established a new “Drug Safety Labeling Changes (SLC)” database that provides these data to the public in downloadable and searchable formats.
There is a hope on the very horizon for people suffering from low back pain. A relatively new procedure known as minimally invasive nerve-ablating procedure seems to be effective in treating some forms of back pain and may offer a new treatment option.
Eli Lilly proved its victory for acquired FDA approval for blockbuster ixekizumab. There is a hope that will compete against a new wave of rival therapies for psoriasis. This drug would be sold as Taltz.
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