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...
'Touchless Plants' To Virtually Trained Workforces - Indian Cos Share Digitalization Tips
Despite AI and digital analytics playing an increasing role in pharma, the industry lags others globally, a recent event heard. Meanwhile, top Indian players including Sun Pharma, Cipla and others shared what is driving their initiatives, ranging from a 'touchless factory' to virtual training and lessons learned along the way.
More IVD Mergers: Agilent Buys Resolution, Hologic Acquires Diagenode
Hologic made its third big acquisition of 2021 and Agilent agreed to pay up to $695m for Resolution Bioscience to extend its precision oncology capabilities.
Merck & Co. Will Manufacture J&J Vaccine, Other COVID-19 Medicines Under BARDA Deal
Broader than initially reported, Merck & Co.’s agreement with BARDA extends beyond J&J’s recently authorized vaccine to other COVID-19 vaccines and therapeutics as needed.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: