Similarly, Lupin said it is facing an API shortage and increased demand, leaving it unable to adequately supply 11 versions of its generic. All Rights Reserved. Zoloft, … The Food and Drug Administration recently added the antidepressant Zoloft (sertraline hydrochloride) to its list of drug shortages. The FDA reported shortages for antidepressant Zoloft as prescriptions rise and ingredients run short. A Hiked-Up Demand 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. The Food and Drug Administration added Zoloft tablets to its list of drugs in shortage on Friday. sertraline FDA Alerts. Contingency plan for secondary API supply source is active. Panic disorder (PD) 4. Current Drug Shortage Bulletins. The efficacy of sertraline for depression is similar to that of other antidepressants, and the differences are mostly confined to side effects. 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. Major depressive disorder (MDD) 2. The antidepressant sertraline (Zoloft) was added to the FDA's shortage list due to increased demand amid the pandemic. Many dosages of Zoloft are still available, according to the FDA shortage list. The FDA Alert(s) below may be specifically about sertraline or relate to a group or class of drugs which include sertraline. Teva states the shortage is due to an active pharmaceutical ingredient shortage. 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: The drug shortage crisis has dominated health care over the past decade. 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. 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. “We are able to supply our historical market share but unable to make up for increased demand,” a Pfizer spokesperson said. Zydus has discontinued the 30 count presentations. Some other doses of sertraline are still available. Revision Date. Zoloft, which is sold under the generic name sertraline, was first approved in the U.S. in 1991. Among them: a leading antidepressant. Current Drug Shortage Bulletins. 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. Johnson & Johnson also reported a "temporary" Tylenol shortage. Generic Name. 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. 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. Manufacturing and packaging utilization and allocation process remains active. 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 … Zydus has venlafaxine extended-release capsules available. Industry can notify the FDA Drug Shortage Staff of new discontinuances, GMP issues, increase in product demand, recalls, supply interruptions, or other events. Erin Fox, a drug shortage expert at the University of Utah, said, “When the F.D.A. »Date first posted: 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. Some other doses of sertraline are still available. »Therapeutic Categories: Pediatric; Psychiatry, Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. 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). Obsessive-compulsive disorder (OCD) 3. 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. Dr. Samantha Meltzer-Brody, Professor and Chair at … Due to the coronavirus pandemic and the stresses caused by it, many Americans … Among them: a leading antidepressant. The demand was so high that soon a shortage of these products became imminent. 1 Sertraline is used to treat several conditions, including major depression, anxiety, obsessive compulsive disorder, and 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. Sertraline (marketed as Zoloft) is included in the class of drugs called selective serotonin reuptake inhibitors (SSRIs). Status: Currently in Shortage Generic Name. 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. The shortage doesn’t impact every sertraline manufacturer, however. Northstar Rx label. Shortages of the antidepressant sertraline (Zoloft—Pfizer), both generic and brand name, have been reported by FDA amid rising demand. 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. Due to the coronavirus pandemic and the stresses caused by it, many Americans … Available Products. The FDA prioritized review of the newly approved generic version of this medicine to address this shortage, he said. Sertraline Hydrochloride Tablets Status: Currently in Shortage »Date first … Social anxiety disorder (SAD) 6. Premenstrual dysphoric disorder (PMDD) 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. 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. 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