US Pharm. 2011;36(6)(Generic Drug Review suppl):3.
Sandoz announced the FDA approval and U.S. launch of its new oral contraceptive brand Loryna (drospirenone 3-mg/ethinyl estradiol 0.02-mg tablets), a generic equivalent of YAZ. Sandoz is the second company to launch a generic version of YAZ, which is indicated for the prevention of pregnancy as well as for the treatment of moderate acne in women at least 14 years of age only if the patient desires an oral contraceptive for birth control.
Among women in the U.S. who practice contraception (approximately 62% of women aged 15 to 44), 28% choose oral contraceptives, which are the most commonly used form of contraception. According to IMS Health, sales for branded and generic versions of YAZ in the U.S. were approximately $578 million for the 12 months ending in February 2011. Sandoz is marketing Loryna in a dosage regimen consisting of 24 active film-coated tablets and four inert (without hormones) film-coated tablets. This dosage regimen is identical to that of YAZ.
Sandoz also announced the FDA approval and U.S. launch of Altavera (levonorgestrel and ethinyl estradiol tablets), a generic equivalent of Nordette (Conceptus). Altavera is a levonorgestrel and ethinyl estradiol combined oral contraceptive indicated for use by women to prevent pregnancy.
