US drug regulators have turned down Ipsen’s effort to slow down generic competition for its blockbuster drug Somatuline Depot, which is used to slow the growth of some tumors as well as for the rare disease acromegaly.
Cipla Limited and its wholly owned subsidiary Cipla USA, announced that it has received the final approval for its Abbreviated New Drug Application (ANDA) for Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL from the United States Food and Drug Administration (USFDA).
The company has received the final approval from the US Food and Drug Administration (USFDA) to market Lanreotide injection in multiple strengths, the Mumbai-based drug maker said in a statement. The company's Lanreotide Injection is therapeutic equivalent generic version of Somatuline Depot Injection, it added
The US District Court for the District of Columbia handed the FDA a rare court win on Monday after Ipsen sued the agency, arguing that the FDA erred in its decision to regulate its blockbuster somatostatin agonist Somatuline Depot (lanreotide) as a drug, rather than a biologic.
DUBLIN, Ireland, and Boston MA, December 5, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the European Commission (EC) approval of Mycapssa® in the European Union (EU) for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is already approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.
Ipsen (Euronext: IPN; ADR: IPSEY) announced today it will invest in a new state-of-the-art electronic autoinjector for Somatuline® Autogel® / Somatuline® Depot (lanreotide), to deliver further innovation in the class with the aim of improving administration and the injection experience for patients. The new device will be made in collaboration with Phillips-Medisize, global leaders in drug-delivery design, development and manufacturing solutions, and will be accompanied by enhanced investment in Ipsen’s Signes manufacturing site in France. This step further builds on Ipsen’s 20 years’ experience with Somatuline Autogel / Somatuline Depot, with today’s announcement marking the fourth generation of devices for its administration.
PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) published today new data from seven abstracts to be presented at the hybrid-setting 19th Annual European Neuroendocrine Tumor Society (ENETS) Conference, 10-11 March 2022, in Barcelona, Spain. Presentations include data from the PRESTO 2 and HomeLAN surveys which demonstrated patient-reported benefits when administering Somatuline® Autogel®/Somatuline® Depot (lanreotide). These include fewer patients reporting experiencing injection-site pain and high levels of injection experience satisfaction when participating in patient support programs (PSP), respectively.
Cipla yesterday said it has received approval from the US health nregulator to market the Lanreotide injection, used for the treatment of nacromegaly and gastroenteropancreatic neuroendocrine tumors, in the nAmerican market.
Cipla and its subsidiary Cipla USA Inc., have received the final approval for Lanreotide injection from the United States Food and Drug Administration (USFDA).
PARIS--(BUSINESS WIRE)--Ipsen (Euronext: IPN; ADR: IPSEY) announced today a total of 9 abstracts presenting new data with a focus in NETs.1-10 These include data from the Phase II CLARINET FORTE study and data on the use of independent administration of lanreotide autogel to be presented at the ENETS Conference, taking place virtually 25-27 February 2021.1-3