New Delhi: Pharma firm Zydus Cadila said it has received final approvals from the US health regulator to market four generic products in America.
The company has received approvals from the United States Food and Drug Administration (USFDA) for Olanzapine tablets, Glipizide extended-release tablets, Voriconazole for injection and Fluocinonide topical solution, Zydus Cadila said in a statement.
Olanzapine tablets have been approved in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg, it added.
The tablets are used to treat Schizophrenia and bipolar disorder. They may also be used in combination with other medications to treat depression, it said.
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 percent, 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.
The group now has 208 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of the filing process by the company, it added.