Despite the startling information about these 27 fatalities – a substance has been recalled from the market (1) with as few as two deaths – FDA officials failed to prevent Prozac from being released.
Instead, it was given final FDA approval on December 29, 1987.
Immunotherapies are beginning to make a mark in this disease, perhaps leaving newcomers on the back foot.
Also the FDA will decide by June 9 whether to approve Coherus Biosciences' (NASDAQ: CHRS) CHS-1701, which could become the first Neulasta biosimilar to market, though ongoing litigation could delay entry.
Welcome to your weekly digest of approaching regulatory and clinical readouts.
In June data are due from a phase II trial testing Acceleron's (NASDAQ: XLRN) dalantercept, an ALK 1 inhibitor, in renal cancer.
Additional documents obtained under the Freedom of Information Act reveal that both Eli Lilly and Co., manufacturer of Prozac, and officials of the FDA were aware that at least 27 deaths had been linked to Prozac’s use before the drug was released.
The proposed regulation would capture e-vapor products that contain or use nicotine derived from tobacco as regulated tobacco products.
Such e-vapor products (including devices and e-liquid) would be subject to the same statutory and regulatory requirements that currently apply to cigarettes, smokeless tobacco and roll-your-own tobacco in a “one-size-fits-all” approach that essentially treats all “tobacco” products the same.
In the face of ever-mounting evidence of the dangers of the psychiatric drug Prozac, the Food and Drug Administration (FDA) has balked at moving against the antidepressant which has accumulated more adverse reaction reports than any other substance in the 24-year history of the FDA’s adverse drug reaction reporting system.
Based on documents recently obtained by FREEDOM under the Freedom of Information Act, as of September 16, 1993, 28,623 reports of adverse reactions to Prozac had been received by the FDA.