fda sertraline shortage

The Food and Drug Administration added Zoloft tablets to its list of drugs in shortage on Friday. The FDA says some drug manufacturers are reporting shortages of the antidepressant Zoloft and its generic, sertraline. Zydus has discontinued the 30 count presentations. Today, reports say that Zoloft, a popular antidepressant drug, is also in short supply. Premenstrual dysphoric disorder (PMDD) Others were expected to be on back order for a … Zoloft, a known antidepressant, is now on FDA's shortage list. Notice from manufacturers to the FDA about impending or current drug shortages allows the FDA to work with the manufacturers to prevent a drastic shortage. Revision Date. The FDA lists all three products as having an expected 60-day shortage, but other details are still fuzzy at this time. Dr. Samantha Meltzer-Brody, Professor and Chair at … For the latest FDA MedWatch alerts, go here. Contingency plan for secondary API supply source is active. “I’ve never experienced a shortage of multiple critical medications to this extent, all at once,” said Esther Choo, an Oregon-based physician told USA Today in May. An agency spokesperson noted that there have been previous shortages of antidepressants, but that Zoloft and generic sertraline have not been in shortage in recent years. That shortage is expected to last 60 days. Status: Currently in Shortage — James Miessler, 300 N. Washington St., Suite 200, Falls Church, VA 22046, USA, Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578, Copyright © 2021. Bloomberg, by way of the FDA’s drug-shortage database , reports that these producers weren’t able to accrue enough of the drug’s active pharmaceutical ingredient, though they did not disclose to Bloomberg where the ingredient is … Drug shortages listed by the U.S Food and Drug Administration (FDA) are exposing some of the ramifications of responses to the COVID-19 pandemic, including state lockdowns and social distancing regulations. Accord Healthcare, InvaGen Pharmaceuticals, Lupin and Pfizer, the blockbuster antidepressant’s brand name manufacturer, have all reported to the FDA that they are experiencing difficulties in supplying the product. According to the FDA website, sertraline producer Accord Healthcare says it is dealing with a shortage because it does not have enough of the drug’s active pharmaceutical ingredients to create it. Twenty-eight generic drugs in 405 dosages made their first appearance on the FDA's shortage list this year, according to a USA Today analysis.. USA Today's analysis found that half of the new shortages are related to the COVID-19 pandemic.The recent shortage additions represent therapeutic categories including ophthalmology, psychiatry, cardiology, oncology and anesthesiology. Northstar Rx label. More than half of those shortages … “At this time, no firm has reported a shortage is anticipated for any drug due to COVID-19,” Caccomo said. Design, CMS, Hosting & Web Development :: ePublishing, We use cookies to provide you with a better experience. Makers of Zoloft (sertraline hydrochloride) and its generic versions are reporting shortages linked to increased demand during the pandemic coupled with supply chain issues caused by the impact of COVID-19 on manufacturers of active pharmaceutical ingredients (APIs). Additionally, generic-drug firms that produce sertraline told the FDA that they weren’t able to get enough active pharmaceutical ingredient, or API, to make the drug. The FDA posted the announcement of the shortage to its website Friday, estimating that it … COVID-19 pandemic causing antidepressant shortage according to FDA The medication in question was identified as Zoloft, which is also known by its generic name sertraline. The shortage doesn’t impact every sertraline manufacturer, however. Search by Generic Name or Active Ingredient: InvaGen Pharmaceuticals (a subsidiary of Cipla Ltd) (, Instructions for Downloading Viewers and Players, Limited supply / orders are being processed as received. Revision Date. Generic Name. Pfizer informed FDA it has a limited supply available of 100-count bottles of 100-mg doses because of a "demand increase" for the drug as people increasingly stay at home to ensure social distancing. The FDA Alert(s) below may be specifically about sertraline or relate to a group or class of drugs which include sertraline. The Food and Drug Administration added Zoloft tablets to its list of drugs in shortage on Friday. In an attempt to subdue the crisis, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on July 7, 2012, 1 which strengthened the agency’s abilities to advance and safeguard public health. The FDA prioritized review of the newly approved generic version of this medicine to address this shortage, he said. For Accord and Lupin, the problems stem from a struggle to obtain the active pharmaceutical ingredient (API) needed to make their generic versions. “We are able to supply our historical market share but unable to make up for increased demand,” a Pfizer spokesperson said. A Springfield pharmacist says people shouldn't panic with the FDA adding Sertraline, the medicine known as Zoloft, to its drug shortage list. The newly approved generic version in short supply ( s ) below be. Mostly confined to side effects ( s ) below may be specifically sertraline... 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