Drug Approval | June 19, 2023
Lupin launches Thiamine Hydrochloride Injection USP in the US
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
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
Urges Innovators to produce quality products that can be deployed at scale
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
The company will submit its comprehensive response on these observations to the US FDA
Collaboration to accelerate and de-risk clinical development of Nanopharmaceutics CNS portfolio
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
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