Emetrol reg letter
Executive Summary
FDA sent Rorer an April 5 regulatory letter saying that continued marketing of the anti-emetic Emetrol is a violation of the FD&C Act, since the product does not comply with the final rule on OTC anti-emetic drugs published on May 2, 1988. The formulation contains "non-permitted active ingredients: dextrose, levulose and phosphoric acid," the letter says. According to Rorer, the letter was referred to Adria Labs, since it now owns Emetrol. Adria acquired Emetrol, along with Rorer's nitroglycerin ointment Nitrol, in an August 1987 product trade agreement. Rorer in turn acquired Adria's analgesic Myoflex.
You may also be interested in...
Pandemic Response In US Consumer Health Market: OTC Pain Relief And Cough/Cold Purchases
Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.
venBio Raises $394m To Fund Biopharmas Through Human Proof-Of-Concept
Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.
FDA Wants To Put Hep C Tests On 510(k) Pathway
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: