Nexus Pharmaceuticals announced today it has received U.S. Food and Drug Administration (FDA) approval for its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial. With no need for compounding, diluting, or mixing, Emerphed saves valuable staff time while also reducing the potential for preparation error and waste.
Enforcement Report - Week of July 25, 2018
is a Dublin, Ireland-based company that merged with France-based Flamel Technologies recently. Avadel has few approved drugs like Bloxiverx (neostigmine inj.), Vazculep (phenylephrine inj.), and Alkovaz (ephedrine inj.). Its marketed products had revenues of $150 million in 2016 (source). The stock has shown a gain on unusual volume recently and we decided to look at this company.
According to the most recent FDA Enforcement reports, Mylan actually began the voluntary U.S. recall of clonazepam in September after discovering the product was out of spec for a known impurity at the 15 and 16 month testing periods. The report indicated they were manufactured at Mylan’s Morgantown, West Virginia, plant. The FDA only posted the recalls for two different strengths in the last week.
Pharma company Avon Lifesciences, which has been in news for a massive drug seizure over the weekend, today clarified that it has all valid licences and statutory registrations for manufacturing, stocking and selling all products manufactured at its Solapur unit and the products seized are in fact stolen from its premises
The diversion of pharmaceutical preparations containing narcotics and precursors like ephedrine and pseudoephedrine to illicit channels in India remains a major challenge for law enforcement agencies, a global body's report has said.