Famy Care wins approval for generic contraceptive
SILVER SPRING, Md. — The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.
The agency approved Famy’s levonorgestrel and ethinyl estradiol tablets in the 0.02-mg/0.1-mg strengths.
The drug is a generic version of Aviane-28, made by Teva Women’s Health, a division of Israeli drug maker Teva Pharmaceutical Industries that previously went under the name Duramed.
FDA approves generic drug for bacterial vaginosis, protozoan infections
SILVER SPRING, Md. — The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.
The FDA approved a generic version of Mission Pharmacal’s Tindamax (tinidazole) made by Unique Pharmaceuticals. The drug is a tablet in the 250-mg and 500-mg strengths.
Tindamax is used to treat bacterial vaginosis, trichomoniasis and giardiasis. The drug has annual sales of about $16.2 million, according to IMS Health.
FDA approves generic antidepressant, anti-smoking drugs
NOIDA, India — The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.
Jubilant, based in India, announced the approval of generic bupropion hydrochloride extended-release tablets in the 100-mg, 150-mg and 200-mg strengths, and another bupropion hydrochloride extended-release tablet product in the 150-mg strength.
The first product is a generic version of GlaxoSmithKline’s antidepressant Wellbutrin SR, while the second is a version of GSK’s anti-smoking drug Zyban.
The total sales of the products per year are $518 million, according to IMS Health. Jubiliant will launch them next year.