Perrigo plans late September launch of a store brand OTC of Nexium 24HR after FDA’s ANDA approval and settlement of patent litigation with AstraZeneca. But it faces competition from Aurobindo's generic OTC esomeprazole 20 mg delayed-release capsules.
Perrigo Co. PLC faces a somewhat unfamiliar challenge of having competition from the start in its upcoming launch of an OTC private label version of Nexium24HR. But with its experience and reputation in private label products, it should seize the top spot among generics of the OTC treatment frequent heartburn and drive its consumer business sales.
Perrigo announced Aug. 21 that FDA granted final approval for its abbreviated new drug application for a store brand OTC...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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