Debiopharm files new Trelstar formulation in US

Nov 18 2008

• By Malini Guha

[C#199100420:Debiopharm] has filed an NDA with the US FDAfor its six-month sustained-release formulation of Trelstar (triptorelin pamoate) for the treatment of locally advanced or metastatic hormone-dependent prostate cancer. If approved, Trelstar will be marketed in the US by [C#198601285:Watson] Pharmaceuticals.

Debiopharm has filed an NDA with the US FDAfor its six-month sustained-release formulation of Trelstar (triptorelin pamoate) for the treatment of locally advanced or metastatic hormone-dependent prostate cancer. If approved, Trelstar will be marketed in the US by Watson Pharmaceuticals.

In September, Ipsen filed the drug under the trade name Decapeptyl in Europe (ScripOnline, October 3rd, 2008).

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

‘Attenuated’ Survival Benefit In Bemarituzumab Trial Delays Filing Plans

Sep 04 2025

• By Alaric DeArment

Amgen and Zai Lab said the final analysis of the FORTITUDE-101 trial showed a decreased magnitude of OS benefit in first-line gastric cancer.

Xoma On Its Royalty Model And Cleaning Up ‘Zombie’ Companies

Sep 04 2025

• By Manas Mishra and Andrew McConaghie

Seizing an opportunity to buy out struggling 'zombie' biotechs, Xoma is helping to return investor cash and pick up potential bargain assets for itself. Its CEO and chief investment officer explained their approach to Scrip.

Genmab/AbbVie’s Epkinly Could Get Competitive Edge With Outpatient Option

Sep 03 2025

• By Alaric DeArment

Phase II data showed it is feasible to give the CD20xCD3-targeting bispecific in the outpatient setting of DLBCL, while its current label calls for hospitalization.

BeOne Preps For Sonrotoclax MCL Filing, With Sights Set On AbbVie/Roche’s Territory

Aug 29 2025

• By Alaric DeArment

The biotech announced positive topline Phase I/II results for the BCL2 inhibitor in late-line mantle cell lymphoma, with Phase III studies underway in chronic lymphocytic leukemia.

AL-S Pharma’s AP-101 Shows Efficacy In ALS Clinical Trial

Sep 04 2025

• By Jessica Merrill

The Phase II study tested AP-101 safety and tolerability as the primary endpoint but showed “clinically meaningful” efficacy in exploratory endpoints.