Allergan filed a declaratory relief action in a US District Court against the FDA, that, if successful, would allow the company to market Botox off-label. Allergan is arguing that some of the off-label uses for Botox are medically accepted and commonly prescribed, but are currently unapproved by FDA. Allergan said in a statement that the law against communicating truthful information to physicians about off-label uses of its products violates the company’s First Amendment rights, and is inconsistent with the Federal Food, Drug & Cosmetic Act. The lawsuit does not include a specific product, but takes issue with the law in general.
Health information transfer and marketing tech firm iMedicor signed an agreement with Access Pharmaceuticals to launch and market MuGard, Access Pharmaceuticals’ oral wound rinse for the management of oral mucositis and stomatitis caused by radiotherapy and/or chemotherapy. MuGard has an estimated worldwide market over $5 billion, according to a company statement. iMedicor will deliver targeted online marketing messages to 216,000 specialty medical practices across the US through its iMedicor portal, as part of the agreement.
