OTC Drugs

Firm’s future, as a separate business nearly 90% owned by Bausch Health, or as a standalone with different ownership or one not controlled by a majority owner, claims high profile in analysts’ comments and predictions. B+L is in the driver’s seat, they say.

Supreme Court’s Loper Bright “decision is central to this case,” says Jonathan Emord, attorney representing Alliance for Natural Health USA and Meditrend Inc. in a complaint filed in US District Court for the District of Columbia.

Reckitt backs up prediction for strong sales during current quarter with advertising featuring a beauty queen and a line extension for Mucinex, one its strongest US consumer health product lines.

FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.

Biden’s order for proposed rules could boost support for Democrat Kamla Harris from undecided voters concerned about reproductive rights or for Republican Donald Trump from those who agree with his conservative stance on access to birth control, which he argues should be up to states to regulate. Proposed rules also could stir consumers not planning to vote to go to the polls.

Kenvue may have to start sharing time with Bausch + Lomb in investors’ discussions about the outlook for success at US consumer health firms separated from former parent firms as they and their competitors begin reporting the results for their latest quarters.

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.

Control of Sanofi Consumer Healthcare – recently rebranded as Opella – may soon pass to US private-equity firm CD&R but the French firm looks set to retain a substantial stake in a business which has some big Rx-to-OTC switches in the pipeline.