Center for Drug Evaluation and Research
FDA Releases New Guidance on Oral Phenylephrine, Xlear Responds
On Nov. 7, the U.S. Food and Drug Administration (FDA) proposed removing oral phenylephrine from over the counter (OTC) medications due to “effectiveness concerns.” According to FDA, oral phenylephrine is widely used as an active ingredient in nasal decongestants. The agency conducted a comprehensive review of all available data on the safety and efficacy of ...
Homeopathic Companies Suspend Marketing of Eye Care Products After Receiving FDA Warning Letters
In September, the U.S. Food and Drug Administration (FDA) sent warning letters to eight companies, including six homeopathic product manufacturers, for “manufacturing or marketing ophthalmic drug products in violation of federal law.” According to FDA, the letters are part of an ongoing effort to crack down on ophthalmic products that are illegally marketed to treat ...
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