Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow
Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.
You may also be interested in...
Why The US FDA Did Not Appreciate Valisure’s Extra Measure Of Protection From Poor Quality Drugs
Unusual citations for DSCSA violations in a recent inspection report and untitled letter from the FDA provide insight into the agency's concerns about the pharmacy that second-guesses the regulatory system it oversees by testing drugs before dispensing them.
FDA’s Scandal In Waiting?
Headlines about potential carcinogens in the drug supply have been a chronic, low-level challenge for the US FDA’s reputation in recent years. A recent Congressional hearing shows how much tinder is now laid for a potential flare up into a full-on crisis in confidence in the agency.
Indian Firms Take Different Paths On Ranitidine
A double blow to ranitidine medicines – suspension in the EU and a withdrawal request in the US – has caused Indian API and formulation manufacturers to recalibrate their strategies. Amid uncertainty over future prospects for the gastrointestinal drug, Strides is considering a relaunch in the US while Solara is reassigning part of its capacity to manufacture other APIs.