Amneal launches liquid generic Lexapro
BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched a generic version of an antidepressant made by Forest Labs.
The drug maker announced the launch of escitalopram oxalate oral solution in 5-mg/5-mL strength in a peppermint flavor, the company said. The product is a therapeutically equivalent alternative to Lexapro and also marks the first generic version of the drug in liquid form on the market.
Amneal said it has begun shipping the product and is available to wholesalers, distributors, as well as directly to the trade.
FDA approves generic version of Lexapro
SILVER SPRINGS, Md. — The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.
The FDA announced the approval of a generic version of Lexapro (escitalopram) made by Teva Pharmaceutical Industries in the 5-mg, 10-mg and 20-mg strengths. The drug is used to treat depression and generalized anxiety disorder in adults.
"These psychiatric conditions can be disabling and prevent a person from doing everyday activities," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options."
Lexapro had sales of $2.8 billion in 2010, according to IMS Health.
Forest files suit over generic versions of hypertension drug
NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.
Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).
Specifically, Forest and Janssen allege that the filings infringe U.S. Patent No. 6,545,040, which is scheduled to expire in December 2021, according to the FDA.