The Pharma Data
FEBRUARY 8, 2021
The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).
The Pharma Data
MARCH 25, 2021
Food and Drug Administration more than six years ago, IBRANCE has been prescribed to more than 380,000 patients across more than 100 countries. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. OS data is being collected in the PALOMA-2 randomized clinical trial but is not yet mature.
The Pharma Data
MAY 13, 2021
Nat Rev Drug Discov. Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. The obesity epidemic and food addiction: clinical similarities to drug dependence. J Psychoactive Drugs. Curr Drug Abuse Rev. Am J Clin Nutr. 1992;55(1):151S–154S. PMID: 1728825.
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