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Bayer HealthCare LLC

Division of Bayer AG
www.healthcare.bayer.com

Latest From Bayer HealthCare LLC

OTC Decisions In March: Lumify Single-Use, Aleve Arthritis-Grip Cap Labeling, And More Prilosec, Mucinex Copies

Total of CDER decisions during March on OTC applications was down from January and February and also were less substantial for the marketplace. After approving OTC switches in first two months, March decisions for newly available OTCs were limited to additional guaifenesin/pseudoephedrine and omeprazole products offered as private label/store brand alternatives to brands.

OTC Drugs FDA

Buying The Coronavirus Vaccine: What Would A ‘Fair And Reasonable’ Price Be?

The US government has a routine approach for negotiating single-seller/single-buyer contracts, but drug pricing politics and public fears of coronavirus will likely complicate any purchasing talks with a sponsor, should an effective vaccine or therapeutic emerge.

Vaccines Infectious Diseases

Bayer's Aleve 'Proven Better' Than Tylenol Claims Fail In J&J Challenge At NAD

Bayer appeals to National Advertising Review Board over NAD’s finding the firm didn't support claims its Aleve OTC provides superior pain-relief to J&J’s Tylenol. It says NAD misunderstands scientific data and it will argue pain studies it submitted were methodologically sound and pain-relief statements were not overly broad.

OTC Drugs Ad Complaints

Bayer Supports Claritin-D Indications Claim, Not Superiority Over GSK's Flonase

Bayer supports making an “8 versus 6 FDA-approved indications” comparison with GSK's Flonase ,but it fails when suggesting Flonase doesn't relieve "sinus congestion and pressure” and “itchy throat” based only on GSK's competing product not receiving FDA approval for those indications, says NAD.

OTC Drugs Advertising, Marketing & Sales
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