Amneal Gets FDA Approval for Generic Hormone Drug

Dow Jones04:24

Amneal Pharmaceuticals received approval from the Food and Drug Administration for lanreotide, a generic brand of a treatment for hormonal diseases.

The product, which will launch immediately, was designated by the FDA as a generic version of Somatuline Depot.

Lanreotide was approved as a 120-milligram injection. It is indicated to treat the hormone disorder acromegaly, as well as advanced gastro-enteropancreatic neuroendocrine tumors and carcinoid syndrome.

The drug helps control hormone levels and improves progression-free survival in eligible patients with cancer. It also reduces the need for rescue therapy in patients with carcinoid syndrome, which is caused by tumors releasing high amounts of hormones.

During the 12 months ended in July, annual sales for Somatuline Depot in the U.S. were $983 million, Amneal said. Somatuline is a registered trademark of the French drug company Ipsen Pharma.

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