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). 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. 1 Sertraline is used to treat several conditions, including major depression, anxiety, obsessive compulsive disorder, and Some other doses of sertraline are still available. 05/29/2020 Among them: a leading antidepressant. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. The Food and Drug Administration recently added the antidepressant Zoloft (sertraline hydrochloride) to its list of drug shortages. The former affected suppliers of the generic version, sertraline. The FDA posted the announcement of the shortage to its website Friday, estimating that it … Generic Name. The FDA lists all three products as having an expected 60-day shortage, but other details are still fuzzy at this time. The efficacy of sertraline for depression is similar to that of other antidepressants, and the differences are mostly confined to side effects. The statement came after an report from Axios on Sunday alleged that FDA had compiled a list of about 150 drugs that are at risk of shortage, which prompted Sen. Josh Hawley (R-MO) to send a letter to FDA. Although it’s engaging in continuous production, the drugmaker said the products will be on back order for a “few months.”, InvaGen, a subsidiary of Cipla, said seven versions of its generic sertraline are on back order, but did not give reasons for the shortages. Northstar Rx label. A spike in demand for anxiety and depression drugs has led to shortages of some forms of the commonly used antidepressant Zoloft and its generic, sertraline. The FDA prioritized review of the newly approved generic version of this medicine to address this shortage, he said. Twenty-eight generic drugs hit FDA's shortage list for the first time in 2020, and experts linked most of the newly added meds to the coronavirus pandemic. The demand was so high that soon a shortage of these products became imminent. Premenstrual dysphoric disorder (PMDD) Citing the impact of COVID-19, Accord said that it is currently unable to support monthly demand for three versions of its generic, including its 500-count 50mg and 100mg versions, because it can’t obtain the API. More than half of those shortages … »Date first posted: The shortage has gotten so bad that EpiPen, in association with the FDA, has even extended the expiration dates of some of its products. “At this time, no firm has reported a shortage is anticipated for any drug due to COVID-19,” Caccomo said. Shortage of top anti-anxiety drug taken by millions could be devastating, doctors warn: A third of supply cut off after FDA found Mylan's West Virginia factory too dirty (Getty Images) The COVID-19 pandemic has tested … Manufacturing and packaging utilization and allocation process remains active. Johnson & Johnson also reported a "temporary" Tylenol shortage. By Admin Team Jun 10, 2020. That shortage is expected to last 60 days. The drug shortage crisis has dominated health care over the past decade. Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, increase in product demand, recalls, supply interruptions, or other events. Due to the coronavirus pandemic and the stresses caused by it, many Americans … Others were expected to be on back order for a … Twenty-eight generic drugs in 405 dosages were added to FDA's list of drugs currently in shortage from January through May, according to a USA Today analysis. 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 … The FDA added Pfizer's antidepressant drug Zoloft and generic sertraline to the list of drugs in short supply amid a spike in demand as the pandemic takes a toll on mental health. Zoloft, which is sold under the generic name sertraline, was first approved in the US in 1991. Teva states the shortage is due to an active pharmaceutical ingredient shortage. Zoloft, a known antidepressant, is now on FDA's shortage list. by Kristen Monaco, Staff Writer, MedPage Today June 3, 2020 The antidepressant sertraline (Zoloft) was added to the FDA's shortage list due to increased demand amid the pandemic. The shortage doesn’t impact every sertraline manufacturer, however. The antidepressant sertraline (Zoloft) was added to the FDA's shortage list due to increased demand amid the pandemic. Pfizer has noted shortages for two of its Zoloft packages, estimating that one would be resolved this month while the timeline for the other is yet to be determined. Some of the shortages of those generics in limited supply were expected to last for the next 2 months, according to the FDA list. Antidepressant Zoloft and generic version in short supply, FDA says. Potts said people shouldn't panic now that the FDA has added Sertraline, the medicine known as Zoloft, to its drug shortage list. 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. 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. Only one of those drugs, chloroquine phosphate tablet, is no longer on the list. API delivery has been delayed due to the impacts caused by COVID-19. 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. June 2, 2020 - The supply of antidepressant drugs has dropped during the coronavirus pandemic, and the FDA placed Zoloft and its generic form on its shortage list on Friday. 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. Dr. Samantha Meltzer-Brody, Professor and Chair at … Product distributed by: McKesson (972-446-4800), Zoloft 25 mg; Bottle of 30 tablets (NDC 0049-4960-30), Zoloft 50 mg; Bottle of 30 tablets (NDC 0049-4900-30), Zoloft 50 mg; Blister of 10 tablets (NDC 0049-4900-41), Zoloft 100 mg; Bottle of 30 tablets (NDC 0049-4910-30), Zoloft 100 mg; Blister of 10 tablets (NDC 0049-4910-41), 25 mg; Bottle of 30 tablets (NDC 59762-6347-1), 50 mg; Bottle of 30 tablets (NDC 59762-6443-1), 50 mg; Bottle of 100 tablets (NDC 59762-6443-2), Next Delivery and Estimated Recovery: March 2022, 50 mg; Bottle of 500 tablets (NDC 59762-6443-3), 100 mg; Bottle of 30 tablets (NDC 59762-5160-1), 100 mg; Bottle of 100 tablets (NDC 59762-5160-2), 100 mg; Bottle of 500 tablets (NDC 59762-5160-3). Today, reports say that Zoloft, a popular antidepressant drug, is also in short supply. Zoloft, a known antidepressant, is now on FDA's shortage list. U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA 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. 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. 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. Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)]: 1. 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 cause, severity, and estimated length of the shortage varies from company to company, based on the information available on the FDA drug shortages database. Due to the coronavirus pandemic and the stresses caused by it, many Americans … The FDA says some drug manufacturers are reporting shortages of the antidepressant Zoloft and its generic, sertraline. Current Drug Shortage Bulletins. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. The FDA announced a shortage of the antidepressant Zoloft and its generic version, sertraline, as the coronavirus pandemic has led to an increase in reports of depression and anxiety in the U.S. Status: Currently in Shortage Obsessive-compulsive disorder (OCD) 3. Erika Edwards. June 3, 2020, 12:57 PM. Generic Name. Contingency plan for secondary API supply source is active. The latest: According to a recent Food and Drug Administration (FDA) report, manufacturers are reporting shortages of sertraline (brand name Zoloft).There are five companies on the shortage list that make the popular antidepressant, which is used to treat depression and anxiety. Drug shortages aren’t unique to the pandemic — … Other companies that manufacture sertraline as a generic have also reported shortages. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. »Therapeutic Categories: Pediatric; Psychiatry, Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. By Admin Team Jun 10, 2020. FDA data show numerous drugs in shortage. Twenty-eight generic drugs in 405 dosages were added to FDA's list of drugs currently in shortage from January through May, according to a USA Today analysis. 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. Shortages of the antidepressant sertraline (Zoloft—Pfizer), both generic and brand name, have been reported by FDA amid rising demand. sertraline FDA Alerts. Some other doses of sertraline are still available. , the U.S. Food and Drug Administration (FDA) added a widely prescribed antidepressant, Zoloft (sertraline), along with several of its generic equivalents to their list of medications reporting current shortages of supply. Erin Fox, a drug shortage expert at the University of Utah, said, “When the F.D.A. FDA data show numerous drugs in shortage. Revision Date. The shortage follows … Social anxiety disorder (SAD) 6. The FDA Alert(s) below may be specifically about sertraline or relate to a group or class of drugs which include sertraline. Two other versions of the product that were in shortage — which were not detailed on the FDA’s drug shortages database — are now back in stock, a Pfizer spokesperson said. Many dosages of Zoloft are still available, according to the FDA shortage list. Shortages of the antidepressant sertraline (Zoloft—Pfizer), both generic and brand name, have been reported by FDA amid rising demand. 28 generic drugs hit FDA's shortage list for the first time in 2020, and experts linked most of the newly added meds to the coronavirus pandemic. Read full article. 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. Back to Search Results, Sertraline Hydrochloride Tablets Among them: a leading antidepressant. Sertraline, sold under the brand name Zoloft among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Sufficient quantities available for current and future demand increases. 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. Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. Revision Date. Sertraline Hydrochloride Tablets Status: Currently in Shortage »Date first … The pharmaceutical companies Lupin Limited and Accord Healthcare both said sertraline would be on back order for at least two months. The Federal Drug Administration (FDA) recently added the popular antidepressant Zoloft (generic name, sertraline) to the drug shortage list. Start Over | 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. For Accord and Lupin, the problems stem from a struggle to obtain the active pharmaceutical ingredient (API) needed to make their generic versions. A report by the FDA found that between 2013 and 2017, approximately 62% of drugs that were in short supply were linked to quality issues or manufacturing problems. 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. Read more on COVID-19 drug shortage Supply Chain API generics antidepressants mental health manufacturing delay U.S. FDA … Sometimes one company’s setback can be another’s opportunity. A Springfield pharmacist says people shouldn't panic with the FDA adding Sertraline, the medicine known as Zoloft, to its drug shortage list. For the latest FDA MedWatch alerts, go here. The FDA requires all antidepressants, including sertraline, to carry a boxed warning stating that antidepressants may increase the risk of suicide in persons younger than 25 years. 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). Zoloft, which is sold under the generic name sertraline, was first approved in the U.S. in 1991. Panic disorder (PD) 4. The FDA said it is working closely with the drugmakers on increasing their supply to respond to the increased demand. “We are able to supply our historical market share but unable to make up for increased demand,” a Pfizer spokesperson said. FDA Alerts: FDA Alerts (6) FDA Alerts (10) FDA Alerts (10) Drug Interactions: A total of 614 drugs are known to interact with sertraline: 140 major drug interactions (558 brand and generic names) 467 moderate drug interactions (1929 brand and generic names) 7 … The FDA reported shortages for antidepressant Zoloft as prescriptions rise and ingredients run short. The Food and Drug Administration added Zoloft tablets to its list of drugs in shortage on Friday. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, U.S. Department of Health and Human Services. “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. Pfizer Inc. said some versions of its name-brand Zoloft, such as 100 milligram tablets in 100-count bottles, were scarce because of higher demand, according to the FDA’s drug-shortage database. Generic Name Revision Date; 0.9% Sodium Chloride Small Volume Bags ( 150 mL) Dec 08, 2020: 14.6% Sodium Chloride Concentrated Solution for Injection : Dec 28, 2020: 23.4% Sodium Chloride Injection: Dec 23, 2020: 5% Lidocaine and 7.5% Dextrose Injection: Dec 07, 2020: 50% Dextrose Injection: Dec 14, 2020: Acetazolamide … 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. Posttraumatic stress disorder (PTSD) 5. 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Only one of those drugs, chloroquine phosphate tablet, is no longer on the list. Major depressive disorder (MDD) 2. Accord Healthcare reported it couldn’t acquire the active ingredient or the drug “due to the impacts caused by COVID-19.” It estimated the shortage will last about 60 days. A Hiked-Up Demand Generic Name Revision Date; 0.9% Sodium Chloride Small Volume Bags ( 150 mL) Dec 08, 2020: ... Sertraline Oral Tablets: Nov 06, 2020: Simethicone Oral Liquid: Nov 24, 2020: Sodium Bicarbonate Injection: Dec 15, 2020: Similarly, Lupin said it is facing an API shortage and increased demand, leaving it unable to adequately supply 11 versions of its generic. The Food and Drug Administration added Zoloft tablets to its list of drugs in shortage on Friday. Among them: a leading antidepressant. Sometimes one company’s setback can be … 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. Design, CMS, Hosting & Web Development :: ePublishing, We use cookies to provide you with a better experience. Zoloft, … Sertraline (marketed as Zoloft) is included in the class of drugs called selective serotonin reuptake inhibitors (SSRIs). 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 made. Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah, provided by ASHP as its exclusive authorized distributor, and used with permission. The FDA prioritized review of the newly approved generic version of this medicine to address this shortage, he said. On Friday, Zoloft, which is sold under the generic name sertraline, was placed on the Food and Drug Administration’s (FDA) list of drugs currently facing a shortage, Bloomberg reported. — 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. Available Products. The FDA said it is working closely with the drugmakers on increasing their supply to respond to the increased demand. Healthy Food FDA data show numerous drugs in shortage. A USA TODAY analysis found 28 generics in 405 dosages hit the Food and Drug Administration's list of drugs in shortage from January through May. All Rights Reserved. Lupin Ltd. said it expects its sertraline to be on backorder for a few months, and Accord Healthcare said it anticipates the shortage will last for two months. Zydus has venlafaxine extended-release capsules available. Zydus has discontinued the 30 count presentations. Current Drug Shortage Bulletins.