Akums Drugs and Pharmaceuticals Ltd., a Contract Development and Manufacturing Organization (CDMO), has announced the launch of Doxylamine + Pyridoxine extended-release tablets, a therapy approved by the CSDCO (Central Drugs Standard Control Organization), India and the United States Food and Drug Administration (USFDA). This marks a milestone as a therapy in India, with a [patent application in process]. Akums’ inventive solution aims to tackle the issues by integrating Doxylamine and Pyridoxine into extended-release tablets.
The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) on Monday said that it’s working on two studies, one of which will focus on Instagram influencers and how people perceive what they say.
Spectrum Laboratory Products Receives FDA Warning Letter
Three years ago, Kim Kardashian caused a ruckus when she touted a morning-sickness pill to her millions of followers on social media. Her posts failed to include any risk information, prompting regulators in the U.S. and Canada to issue stern warnings.
Previously unpublished information from the clinical trial that the US Food and Drug Administration relied on to approve the most commonly prescribed medicine for nausea in pregnancy indicates the drug is not effective, a new report says.
Kardashian in 2015 endorsed the medication, sold as Diclegis in the United States, in a 2015 Instagram post that spurred the Food and Drug Administration to send a warning letter to Duchesnay, the Canadian company that makes the drug. Kardashian, who was paid by Duchesnay, failed to include any information about the drug’s risks. (Duchesnay’s latest celebrity spokeswoman is “lifestyle expert” Emily Maynard Johnson, best known for her appearances on “The Bachelor” and “The Bachelorette.”)