As far as I can tell, it will not be approved ever. The product Teva is trying to pass off to the FDA as a generic copy of Lovenox was developed and is manufactured by the Italian company, ItalFarmaco. It’s essentially the same drug that ItalFarmaco licensed to India’s Lupin for sale in India under the brand name, Lupenox. Teva’s role in the project is limited to the FDA submissions and the prospective US distribution. All this comes from a well-placed source in the industry.
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