Well thank you FDA for bringing this to our attention as clinical trials today versus what they were when the drug was created has grown and only 1% of our over all sales are attributed to this drug, so we’ll just throw in the towel here and take the drug off the market.
The drug was approved in 1996 so as I commented above the company is basically saying “see you later” if what we submitted didn’t fill the requirements. Perhaps the 2 may end up sitting down and maybe coming to a better conclusion? The drug has been out there for over 14 years and has some generic companies using the formulation now too.
This is kind of crazy as if the FDA needs data, get it from some pharmacy benefit managers or insurance companies at this point, they’ll have it as they have tons of everyone’s data when it comes to how drugs are working these days as they need the information to generate their own approved formularies.
The 2 go hand in hand and since 1996 there’s of ton of data gathered here. The company actually had notified the FDA back in 2009 about withdrawing the product from the market. BD
LONDON (Dow Jones)--Drug maker Shire PLC (SHP.LN) Tuesday said it will remove its low-blood pressure drug ProAmatine from the market, as it isn't profitable enough to justify the additional clinical tests U.S. regulators are demanding to maintain its marketing authorization.
But a Shire spokesman Tuesday said, "Shire did conduct and complete the post-marketing trials that the FDA required--however, the FDA viewed these trials as inconclusive and, as a result, said additional trials associated with ProAmatine are needed in order for this medicine to maintain its marketing authorization in the U.S."
The FDA first approved the drug in 1996 under the agency's accelerated-approval mechanism. That mechanism allows drugs to be approved on clinical data that suggests a drug has benefit but requires follow up studies to prove a product works.