Drug Approval | June 24, 2023
Ipca Laboratories receives 8 observations from USFDA
The company will submit its comprehensive response on these observations to the USFDA
The company will submit its comprehensive response on these observations to the USFDA
This product will be manufactured at Lupin's Pithampur facility in India
This trial is a multi-national, phase 2/3, open-label, randomized, controlled clinical study of utidelone injectable
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.
Columvi is part of Roche's industry-leading portfolio of T-cell engaging bispecific antibodies in non-Hodgkin lymphoma, which also includes the recently approved Lunsumio to treat follicular lymphoma
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
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
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
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