Perrigo Co. PLC likely will be first to market with a generic version of Reckitt Benckiser Group PLC’s Mucinex as it prepares to launch the OTC expectorant by April following a court ruling against Reckitt’s patent claim.
Perrigo Sets Generic Mucinex Launch After Patent Claim Decision
The private labeler clears a Reckitt Benckiser legal hurdle and will launch generic Mucinex (guaifenesin) by April. Watson has filed ANDAs for three Mucinex products and could be a good strategic partner for Perrigo, an analyst suggests.
More from United States
US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease
Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.
Consumer and academic group comments on accelerated approval and confirmatory trial guidances say the proposed criteria for determining when a study is underway are too vague.
Bavarian Nordic's Vimkunya added the US CDC immunization committee's recommendation to its FDA approval, while Valneva's Ixchiq faces a precaution for use in people aged 65 and older.
More from North America
In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.