FDA Approves Somatuline Depot for Acromegaly
On August 31, 2007, the US Food and Drug Administration (FDA) approved Somatuline depot (lanreotide) injection 60, 90, and 120 mg for marketing in the United States.
On August 31, 2007, the US Food and Drug Administration (FDA) approved Somatuline depot (lanreotide acetate injection) 60, 90, and 120 mg for marketing in the United States. Somatuline depot, manufactured by Tercica, Inc. (Brisbane, CA, www.tercica.com), is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery or radiotherapy, or for whom surgery or radiotherapy is not an option. Somatuline depot will be available in a pre-filled syringe eliminating the need for reconstitution. Somatuline depot is expected to launch in the United States in the fourth quarter 2007.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
