FDA Approves DOXEPIN HYDROCHLORIDE — Leading Pharma, LLC

Leading Pharma, LLC announced the FDA approval of its ANDA for doxepin hydrochloride on March 9, 2021, enabling the launch of this oral anticholinergic treatment. The approval is poised to bolster Leading Pharma’s portfolio and intensify competition in the generic doxepin market, likely exerting downward pressure on pricing for brand-name competitors.