Jerusalem – Teva Pharmaceutical Industries Ltd on Friday said it hopes to win U.S. approval by late 2017 or early 2018 for its version of Mylan NV’s EpiPen device to treat severe allergic reactions, a move that could challenge the branded product’s overwhelming dominance.
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The Israeli drugmaker, in a webcast overview of its generics medicines business, said it plans to meet with the U.S. Food and Drug Administration about potentially re-submitting Teva’s U.S. marketing application for the device. The FDA in February declined to approve the product, citing dosage problems.
Sigurdur Olafsson, Teva’s head of global generic medicines, said the company had been attempting to secure a meeting with FDA officials after its product was rejected, and that agency officials reached out to the company in recent weeks.
Hope FDA will change and start care about Americans not corrupt politicians who work for Pharma companies and care only about monies.
Its crazy, with prices of drugs scyrocating, people soon would not efford to stay alive.
The risk is that as soon as a generic is approved Mylan will present their own generic at a low price and leave no sales for TevaI. It iis not unheard of for a brand name to sell the same drug through a susidiary to steal sales from generics. The ultimate winner in the market is the firm with volume and lowest cost of production, likely the brand name producer.
It is interesting that it seems as though the FDA was playing a stall game to protect Mylan till it became an issue.
yes. but when it comes to your health you cant put a price on it. well of course there are the insurance premiums and deduductibles and copays and co insurance and lifetime maximums and percentage limits and uncovered procedures and out of Network costs and of course procedures deemed cosmetic and then there are the waiting periods, diffrent tiers or medications, in patients costs vs out patient costs, types of anesthesiology allowed….