Switch consultant Susan Levy suggests drug firms temper enthusiasm for Rx-to-OTC switches with considering the costs NDAs generate and the histories of switches that haven’t been successes.

CRLs FDA submits in response to ANDAs increased most years since FY 2015, though FY 2020 total likely will be lower than two previous years. A 2019 CRL interrupted GSK's plans to market first mouth spray nicotine replacement therapy in US.

Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals. 

Bausch seeks to add eyecare assets in Allegro deal. AstraZeneca hopes preclinical PCSK9 inhibitor from Dogma can compete with dyslipidemia leaders. Exelixis options ADC candidates from Catalent and NBE.