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“Today’s approval is especially important for more vulnerable populations. Toxoplasmosis Infectious diseases such as Pregnant Women and individuals HIV Or AIDSBy increasing the options for treatment options. ” FDA Commissioner Dr. Steven Hahn said in a news release from the authorities.
Dalaprim It was first notorious when its manufacturer, Turing Pharmaceuticals, raised the price of the drug from $ 13.50 per tablet to $ 750 by 5,000%. CNN report.
Martin Shkreli, then CEO of the company, is said to have become known by the name “Pharma Bro”. CNN..
A new generic version of the drug is approved for use with sulfonamides, a group of drugs used for treatment Bacterial infectious disease..
Toxoplasmosis Is an infectious disease caused by a parasite called Toxoplasma gondii, This can be contracted by: Eating poorly cooked and contaminated meat or crustaceans. Drinking water contaminated with parasites; or accidentally swallowed parasites through contact with cat feces containing it.
In severe cases, it can damage the brain, eyes and other organs. Toxoplasmosis According to the FDA, it is the leading cause of food poisoning-related deaths in the United States.
However, even those with a healthy immune system may suffer from eye damage from toxoplasmosis.
Newly approved generic version Pyrimethamine The tablet is made by Cerovene Inc.
“Through the FDA’s Drug Competition Action Plan, we have endeavored not only to improve the efficiency of generic drug development, review and approval, but also to remove barriers to generic drug development. DrugNot only by closing loopholes that allow branded pharmaceutical companies to “game” the rules in a way that delays the generic competition intended by Congress, “Hahn said.
“These important efforts include improving access to safe, effective and high-quality generics,” he said.
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Source: US Food and Drug Administration, News Release, February 28, 2020
FDA Approves First Generic Version of Dalaprim, Best Known as “Pharmabro” Drug
Source link FDA Approves First Generic Version of Dalaprim, Best Known as “Pharmabro” Drug