US OTC Switch Drought Ends: FDA Approves GSK Arthritis Gel, Alcon Allergy Eye Drops
FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.
You may also be interested in...
US Proposed ACNU Rule Rings Bell About Rx Drugs Marketed After NDAs Eliminated With OTC Switches
Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.
Akorn's Delay Moving Three Generics To OTC Leads To $7.9M Settlement In Medicare Billing Complaint
Akorn agrees with DoJ to pay $7.9m to settle allegations it deliberately sold three as Rx three ingredients moved to OTC. Mislabeling led Medicare Part D to pay for the drugs for around a year despite the products not being eligible for coverage.
Haleon’s EMEA Head Filippo Lanzi: There’s More To Innovation Than Rx-To-OTC Switch
Health literacy and natural alternatives are two areas where Haleon's EMEA and LATAM head Filippo Lanzi sees potential for growth, in addition to Rx-to-OTC switch, he tells HBW Insight in an exclusive interview. Lanzi also digs deeper into Haleon's recently published first-half sales and earnings results and shares his thoughts on how the firm will meet the multiple challenges posed by the current social and economic environment.