Pharma firm Zydus Cadila has said that it received final approvals from the United States Food and Drug Administration (USFDA) to market four generic products in America.
Zydus Cadila in a statement said it received US health regulator’s nod for four generic products which are Olanzapine tablets, Glipizide extended-release tablets, Voriconazole for injection and Fluocinonide topical solution, Zydus Cadila.
Olanzapine tablets have been approved in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg, statement said. The tablets are used to treat Schizophrenia and bipolar disorder.
Glipizide extended-release tablets in the strengths of 2.5 mg, 5 mg and 10 mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, it added.
The company has also received approval from the US health regulator to market Voriconazole for injection 200 mg single-dose vial.
The product is indicated for use in various fungal infections, it added.
“These three products will be manufactured at the group’s manufacturing facility at Moraiya, Ahmedabad,” Zydus Cadila said.
The fourth product, Fluocinonide topical solution 0.05 per cent, is used to treat a variety of skin conditions and reduces the swelling, itching, and redness that can occur in these conditions, it added.
The product will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, Zydus Cadila said.