Enforcement Report - Week of August 9, 2023
[August 1, 2023] FDA is warning consumers that two lots of Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium), a prescription oral contraceptive (birth control pill) manufactured by Lupin Pharmaceuticals, may have reduced effectiveness due to decreased levels of ascorbic acid, an ingredient, in the product.
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point
Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™
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.
Lupin's Generic Drospirenone Receives Approval in the U.S.
Drug maker Lupin on Friday said it has received approval from the US health regulator to market Drospirenone tablets, used to prevent pregnancy, in the American market. The company has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA), Drospirenone Tablets in 4 mg strength, the Mumbai-based drug maker said in a statement.
The decision to prescribe it takes into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism. This announcement comes approximately a year after the Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK licence for E4/DRSP.
Gedeon Richter has announced that its combined oral contraceptive Drovelis® is the first tablet containing estetrol (E4) and drospirenone (DRSP) to be made available on the NHS in England.