A new generic epilepsy drug has been conditionally approved by the FDA. Officials from Supernus Pharmaceuticals Inc., the manufacturers of the drug, have stated that the FDA granted the company a tentative (experimental) approval for Trokendi XR.
Supernus has said that FDA approved the drug after the agency reviewed Trokendi, which is an extended release version of Johnson & Johnson’s Topamax. The agency approved Trokendi without seeking any more clinical trials than those provided before making the approval application.
Since Topamax is no longer protected by its patent, generic versions are ripe for development. Even though Trokendi has been tentatively approved, it won’t win its final approval from the FDA until Supernus resolves a marketing exclusivity issue that the FDA is concerned about. Topamax is also used to treat migraines and Trokendi may be used for the same purpose, as well. With so much of the population affected by epilepsy, Topamax and other anti-seizure medications are looked at as miracle drugs when they work. However, because these drugs harm people more than they help them, they can become a burden instead of a savior.
Chances are the fact that Topamax is linked to birth defects in babies whose mothers take the drugs while pregnant is going to be an issue as well once Trokendi hits the market. Some of those birth defects linked to Topamax include PPHN, oral clefts, neural tube defects and heart, lung and brain defects.
If your baby was born with any of these birth defects after being exposed to Topamax during gestation, contact Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your baby’s injuries.
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