Jul 06

AVANIR expects the FDA to classify the response as a Class 2 resubmission.

AVANIR expects the FDA to classify the response as a Class 2 resubmission, which would result in an expected review period of 180 days and potential authorization of Zenvia in the fourth calendar quarter of 2010. ‘With the help and assistance of the FDA, we could actually improve the benefit-risk profile of Zenvia with brand-new low dosage formulations that we believe, if authorized by the FDA, can be utilized safely and efficiently by patients suffering from the often disabling condition of PBA.’ ‘We are thrilled to have filed our Total Response with the FDA,’ said Randall Kaye, MD, AVANIR’s Chief Medical Officer.‘It really is puzzling that the [research] authors believe regulation of vapor items will somehow address the usage of marijuana products that already are unlawful for minors to possess in all 50 states,’ Conley said. ‘The FDA is empowered to modify nicotine-containing vapor products, therefore marijuana vaping products will only be regulated if a massive change in U truly.S. Drug laws happen,’ he added. ‘The e-cigarette cartridges and tanks that are capable of vaporizing THC oil or wax are generally specifically designed for marijuana,’ Conley explained. ‘These are not similar products being sold in vape shops and convenience stores.’ Clarkin said he’s particularly concerned that kids will receive a more potent dose of THC when they vape marijuana.