The FDA appears to be complicit in the situation, since it gave approval to KV a month ago, even though compounding pharmacies had been making the drug on an ad hoc basis for many years prior.
Once KV had a monopoly to sell 17P it raised the price per dose more than 100-fold.
The biggest winner in biotech last month was KV Pharmaceuticals, a heretofore unknown drug maker whose new drug to treat pre-term birth was approved but the Food and Drug Administration on Feb. 4.
At the same time, KV Pharma filed a lawsuit against the FDA for failing to take action against compounders ( find it here), and also sued Georgia and South Carolina for restricting Makena coverage ( link to lawsuits are here).
American Electric Power plans to deploy Ti for the first time on a 765 kV transmission line in 2014.
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It works by using a power source to pump 10 kV of juice to an electrode, which then polarizes a dielectric plate, causing it to attract your body hair.
An even more dramatic example was the approval of Makena, a drug made by KV Pharmaceutical of St.
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As a result, he granted a preliminary injunction to KV Pharma, because the drugmaker is likely to be able to demonstrate that Georgia Medicaid is violating the law by failing to cover Makena ( here is the ruling).
On a slightly smaller scale, there's the huge Siemens breaker I saw at the Bonneville Power Administration. (If you're thinking of buying one as an art object, ask your dealer for a Siemens 72.5 kV SF6 sulfur hexafluoride power circuit breaker).
Anybody, I suppose, with the right manufacturing equipment and a good lobbyist could have done what KV did.
Patient advocates and the FDA had worked with KV to get Makena approved in the hopes that a safer, branded version would be better for moms and babies.
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In most other countries, KV Pharmaceutical would never be allowed to get away with such a thing.
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As KV Pharma followers may recall, Makena was originally projected to become a big moneymaker after the FDA approved the treatment early last year under the Orphan Drug Act.
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