Teva Pharmaceuticals slammed with €462.6m fine for blocking Copaxone competitors

Teva Pharmaceuticals slammed with €462.6m fine for blocking Copaxone competitors

Teva Pharmaceuticals, the generics powerhouse, has been slapped with a hefty fine of €462.6 million by the European Commission for anti-competitive practices related to its blockbuster multiple sclerosis drug, Copaxone. The fine marks one of the largest penalties imposed on a pharmaceutical company for breaching antitrust regulations in recent years, surpassing the penalty imposed on […]

FDA approves Alvotech and Teva Pharmaceuticals’ SELARSDI as biosimilar to Stelara

FDA approves Alvotech and Teva Pharmaceuticals’ SELARSDI as biosimilar to Stelara

In a significant development in the pharmaceutical industry, Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), have announced the approval of SELARSDI (ustekinumab-aekn) injection by the U.S. Food and Drug Administration (FDA). This approval marks SELARSDI as a biosimilar to Stelara, designed for the treatment […]

FDA approves biosimilar SIMLANDI by Alvotech and Teva Pharmaceuticals

FDA approves biosimilar SIMLANDI by Alvotech and Teva Pharmaceuticals

Alvotech and Teva Pharmaceuticals have achieved a significant milestone with the U.S. Food and Drug Administration’s (FDA) approval of SIMLANDI (adalimumab-ryvk) injection. This approval positions SIMLANDI as an interchangeable biosimilar to Humira, a leading treatment for various arthritis and inflammatory conditions. The approval covers a wide range of conditions, including adult rheumatoid arthritis, juvenile idiopathic […]

Teva Pharmaceuticals, MedinCell get UZEDY FDA approval for schizophrenia

Teva Pharmaceuticals, MedinCell get UZEDY FDA approval for schizophrenia

Teva Pharmaceuticals and MedinCell have bagged approval for UZEDY (risperidone) extended-release injectable suspension from the US Food and Drug Administration (FDA) for schizophrenia treatment in adults. UZEDY is a subcutaneous, long-acting formulation of risperidone that uses MedinCell’s copolymer technology SteadyTeq that regulates the fixed release of risperidone. Therapeutic blood concentrations are achieved within six to […]

NATCO Pharma launches lenalidomide 2.5mg and 20mg in US

NATCO Pharma launches lenalidomide 2.5mg and 20mg in US

NATCO Pharma said that it has launched additional strengths for the generic version of Revlimid (lenalidomide capsules), in the strengths of 2.5mg and 20mg in the US. The Indian pharma company has launched the product through its marketing partner Teva Pharmaceuticals, which is a US-based affiliate of Israeli pharma company Teva Pharmaceutical Industries. With the […]

Teva Pharmaceutical gets FDA approval for AUSTEDO XR for TD and HD

Teva Pharmaceutical gets FDA approval for AUSTEDO XR for TD and HD

Teva Pharmaceutical Industries said that its US affiliate Teva Pharmaceuticals has secured approval for AUSTEDO XR (deutetrabenazine) extended-release tablets from the US Food and Drug Administration (FDA) for tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD). AUSTEDO XR is a new daily once formulation. Expected to be launched in the US later this […]

Teva launches generic version of Delzicol delayed-release capsules in US

Teva launches generic version of Delzicol delayed-release capsules in US

Israeli pharma company Teva Pharmaceuticals has launched a generic version of Delzicol (mesalamine) 400mg delayed-release capsules in the US. Mesalamine Delayed-Release capsules are an aminosalicylate, approved for the treatment of mild to moderate ulcerative colitis in patients aged five years and above, and also for maintenance of remission of ulcerative colitis in adult patients. Brendan […]