Levomefolate calcium

Phalguni Deswal @Phalguni_GD The US FDA recently approved Perrigo’s Opill (norgestrel), which does not require a prescription. Credit: Africa Studio / Shutterstock. The US Food and Drug Administration (FDA) has issued a customer warning for Lupin Pharmaceuticals’ oral birth control pill Tydemy. The FDA warns of reduced efficacy of Tydemy due to decreased levels of one of the inactive ingredients, ascorbic acid. Recommended Reports Reports LOA and PTSR Model - Zoliflodacin in Uncomplicated Cervical And Urethral Gonorrhea GlobalData Reports LOA and PTSR Model - Palonosetron Hydrochloride La in Chemotherapy Induced Nausea and Vomiting GlobalData View all Companies Intelligence Lupin Ltd Perrigo Company Lupin Pharmaceuticals Inc NDC View all The reduced efficacy is associated with two US lots, L200183 (expiry date January 2024; NDC Number 68180-904-71) and L201560 (expiry date September 2024; NDC Number 68180-904-73) distributed from 3 June 2022 to 31 May 2023. On 28 July, Lupin issued a voluntary recall for the two lots following an out-of-specification (OOS) test reporting low levels of ascorbic acid and high levels of a known impurity in the L200183 lot. Tydemy (drospirenone / ethinyl estradiol / levomefolate calcium) is a prescription oral contraceptive that prevents pregnancy by raising folate levels. As per Lupin ’s 28 July press release , the reduction in ascorbic acid could impact Tydemy’s efficacy and could lead to an unexpected pregnancy. The US FDA recently approved Perrigo’s Opill (norgestrel) , which does not require a prescription, while many other contraceptives such as Tydemy need one. Global sales of contraceptives are expected to reach £8.2bn by 2027, as per GlobalData forecasts. GlobalData has also identified an unmet need for hormone-free birth control pills. To that end, Singapore-based Navad Life Sciences is developing an oestrogen-free oral contraceptive , NA-0113, which is currently in a Phase II trial. GlobalData is the parent company of Pharmaceutical Technology . Other women’s health drug in Lupin’s pipeline includes Solosec (secnidazole), which is marketed for bacterial vaginosis.

BALTIMORE, Md, July 29, 2023 /PRNewswire/ --Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at the 12-month stability time point. Specifically, one lot (L200183) tested low for ascorbic acid (an inactive ingredient) and high for a known impurity. Continue Reading Product Pack (PRNewsfoto/Lupin Pharmaceuticals, Inc.) To date, Lupin has received no reports of adverse events related to either recalled lots. Regardless, Lupin is recalling two lots because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy. Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Tydemy is packaged in 28's blister. One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton. The lots were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below: Lupin is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots. Patients taking, Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. Wholesalers, distributors and retailers that have Tydemy that is being recalled should discontinue distribution of the recalled product lots immediately. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Product Label: About Lupin Pharmaceuticals Lupin Pharmaceuticals, Inc. is the U.S. based wholly-owned subsidiary of Lupin Limited and is the 3rd largest pharmaceutical company in the U.S. based on total prescriptions. Together, all Lupin-owned entities combine to make up the 8th largest generic pharmaceutical company in the world by revenue size. Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality medications across many treatment areas. Lupin Pharmaceuticals Inc.'s branded pharmaceuticals division, is the provider of products designed to help prevent and manage women's health conditions with serious health consequences. Photo - SOURCE Lupin Pharmaceuticals, Inc.