Drug Approval | June 19, 2023
Lupin receives EIR from FDA for its API manufacturing facility in Vizag
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with the facility receiving an inspection classification of NAI
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
Convergent action on AMR identified as an important area of intervention
The inspection closed with zero observations
Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Granules now has a total of 58 ANDA approvals from US FDA
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
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
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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