Drug Approval | July 26, 2023
NATCO files generic Erdafitinib Tablets in USA
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
Mage Biologics to develop a monoclonal antibody targeting ulcerative colitis
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
The application is in line with Innocan's strategy to expand the scope of its combined magnesium and cannabis topical solution
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Subscribe To Our Newsletter & Stay Updated
