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Tag Archives: Drug Approval

505(b)(2): A New Drug Approval Pathway

05 Wednesday Jul 2017

Posted by AAPS Blog in Current Perspectives

≈ 1 Comment

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505(b)(2), Aniruddha Railkar, Drug Approval, drug pricing, FDA, FFDC

By Aniruddha Railkar

According to a 2014 report by the Tufts Center for the Study of Drug Development, the cost of developing a new drug is $2.6 billion. That is a 145% increase, adjusted for inflation, over their 2003 estimates. This report has been criticized and praised, but the reality is that developing a new drug is an expensive and time consuming process (on an average it takes 12 years to go from discovery to commercialization). Continue reading →

Altered “Me-Too” Drug

28 Tuesday May 2013

Posted by AAPS Blog in Breaking Pharmaceutical News

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Abimbola Farinde, Drug Approval, FDA, Lipid

Abimbola FarindeAbimbola Farinde, Pharm.D., is a clinical pharmacist specialist with specializations in psychopharmacology and geriatrics.

In an effort to increase the probability of effectively treating hyperlipidemia, the Food and Drug Administration (FDA) recently approved another lipid lowering agent, Merck’s Liptruzet (ezetimibe and atorvastatin). The approval of this “me-too” drug adds to the growing list of available therapeutic options that specifically target the management of primary or mixed hyperlipidemia as an adjunctive therapy to diet when diet alone does not successfully lower cholesterol.

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