Lupin launches generic oral contraceptive tablets in US
New Delhi: Pharma major Lupin said it has launched its Tydemy tablets, indicated for use by women to prevent pregnancy, in the US.
The launch follows the approval from the US Food and Drug Administration (USFDA) of Tydemy tablets (Drospirenone, Ethinyl Estradiol, Levomefolate Calcium, 3mg/0.03mg/0.451mg and Levomefolate Calcium, 0.451mg), the company said in a statement.
The approved Tydemy tablets are generic equivalents of Bayer HealthCare Pharmaceuticals Inc's Safyral tablets, Lupin said.
The medicine is indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception, it added.
Drospirenone, EE, Levomefolate Calcium, 3mg/0.03mg/0.451mg & Levomefolate Calcium, 0.451mg tablets had annual sales of approximately USD 22 million in the US as per IQVIA data for January 2018.