Mylan sues over Prilosec OTC
Procter & Gamble's Prilosec OTC is falsely represented as identical to AstraZeneca's prescription version of the proton pump inhibitor, Mylan alleges in a Manhattan federal court lawsuit. Mylan also recently submitted a study to FDA that the company asserts demonstrates OTC omeprazole is not bioequivalent to Prilosec. P&G maintains the Rx and OTC 20 mg formulations are the same. Mylan alleges P&G's claims will divert sales from its own generic omeprazole, which launched "at risk" in August (1"The Pink Sheet" Aug. 11, 2003, p. 11)...
You may also be interested in...
Mylan's decision to launch the second generic version of AstraZeneca's Prilosec (omeprazole) could inject a new level of price competition into the proton pump inhibitor category
Pink Sheet Podcast: COVID Vaccine In Adolescents, CMS Drug Pricing Moves, Standard Care In Clinical Trials
Pink Sheet reporters and editors discuss the US FDA decision to lower the eligibility age for the Pfizer/BioNTech COVID-19 vaccine, CMS drug pricing project plans, and mid-stream standard of care changes in drug development.
Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker