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.
Teva’s Pliva division increases manufacturing capacity by more than 25%
ZAGREB, Croatia — Teva Pharmaceutical Industries is investing more than $100 million in its Croatian division for a plant that will make pills mostly for the international market.
Teva subsidiary Pliva said the new plant, in the capital of Zagreb, would considerably increase its production capacities for tablets and capsules. The company said the new plant would increase the annual manufacturing capacity by more than 25%.
"This year has been especially important for us — we are about to complete one of the largest investment cycles in the company’s history," Pliva management board president Tihomir Orešković said. "I am glad that Teva is today one of the biggest private investors in Croatia and that its investments in the production facilities in Zagreb and Savski Marof total more than $200 million."