Drug Approval | July 14, 2023
Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
Mindset disagrees with and denies the allegations set forth from Reunion.
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer
Ryzneuta is a novel dimeric G- CSF long-acting fusion protein without pegylation. The Biologics License Application (BLA) of Ryzneuta is currently under late-stage review by the US FDA for Chemotherapy-Induced Neutropenia (CIN)
The ninth acquisition since 2018
The two-year agreement will grant Lonza access to IBF's prominent network and allow IBF to benefit from Lonza's manufacturing expertise and knowledge in its due diligence review of potential targets
The production suspension impacts commercial and clinical trial supply
Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)
Subscribe To Our Newsletter & Stay Updated
