US-based Jubilant Cadista Pharmaceuticals is recalling a number of Drospirenone and
Ethinyl Estradiol Tablets, USP, 3mg/ 0.02mg, 28x3 Blister Pack/Carton that had been on sale to consumers, it was reported yesterday.
"We wanted to prove whether the segesterone in combination with the low dose of
ethinyl estradiol in this unique vaginal system was adequate at inhibiting ovulation and pregnancy as well as providing good cycle control," Archer said.
In the present study, the most common contraceptives used by pregnant women were medroxyprogesterone acetate, pharmaceutical combination form of estradiol valerate+norgestrel, and pharmaceutical combination form of
ethinyl estradiol+levonorgestrel.
sales for drospirenone and
ethinyl estradiol tablets USP, 3 mg/0.02 mg were approximately $161 million for the 12 months ended February 28, 2018, according to IQVLA.
Aromatization of norethindrone to
ethinyl estradiol by human placental microsomes.
The company said the Annovera (segesterone acetate and
ethinyl estradiol vaginal system) is the first a new class of contraceptive that provides an entire year of protection against unintended pregnancy while fully under a woman's control.
A study done in Baghdad showed combination of spironolactone and cOCPs (containing levonor-gestrel 0.15 mg/
ethinyl estradiol 0.03mg) to have a response rate of 60%8 but this study utilized the hair shaft diameter as their response parameter.
All received a daily OC (Ortho-Cyclen; 250 meg norgestimate, 35 meg
ethinyl estradiol).
Furthermore, cycle control with the combined vaginal contraceptive ring has been shown to be superior to that with a combined OCP containing 30 [micro]g
ethinyl estradiol and 150 [micro]g levonorgestrel (10, 11) or 3 mg drospirenone (12).
The COCs that contain drospirenone as the progestin component are Yasmin (0.03 mg of
ethinyl estradiol with 3 mg of drospirenone), approved in 2001, the first COC that contained drospirenone; Yaz (0.02 mg of
ethinyl estradiol with 3 mg of drospirenone), approved in 2006; and Safyral and Beyaz, folate-containing versions of Yasmin and Yaz, respectively, which were approved in 2010.
Pharmaceutical giant Pfizer has recalled 1 million packages of pills--14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and
Ethinyl Estradiol tablets--after uncovering a packaging error that included too many active tablets in some packets and not enough in others.
(The OCs with desogestrel or gestodene and 20 mcg of
ethinyl estradiol implied relative risks of VTE that were 23% and 17% lower, respectively, than the risks for the same progestogens with 30 mcg of
ethinyl estradiol.)