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.

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.