Amneal Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its lanreotide injection, 120 mg/0.5 mL, supplied as a sterile, single-dose prefilled syringe. The company said the product, which references Somatuline Depot, is available for immediate launch in the US.

The product has also received Competitive Generic Therapy (CGT) designation from the FDA, a designation intended for certain generic drugs where limited competition exists in the market.

Lanreotide injection is indicated for the treatment of acromegaly, advanced Gastro-Enteropancreatic Neuroendocrine Tumours (GEP-NETs) and carcinoid syndrome.

In patients with acromegaly, lanreotide helps control hormone levels. For eligible patients with GEP-NETs, the treatment is used to improve progression-free survival, while in patients with carcinoid syndrome, it can reduce the need for rescue therapy.

Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines at Amneal Pharmaceuticals, said the approval and launch of lanreotide would add another growth driver to the company’s Affordable Medicines business.

He said the product expands Amneal’s complex injectable portfolio and reflects the company’s integrated development and manufacturing capabilities.

Amneal said its dedicated, large-scale in-house manufacturing capacity is expected to support reliable supply of the medicine in the US market while expanding access to lanreotide.

The launch further strengthens Amneal’s presence in complex injectable medicines and adds another product to its portfolio of specialty and affordable pharmaceutical therapies.