Zydus Cadila gets USFDA nod for antihistamine drug
New Delhi: Drug firm Zydus Cadila said it has received approval from the US health regulator to market antihistamine Cyproheptadine Hydrochloride tablets in the US market.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market Cyproheptadine Hydrochloride tablets in the strength of 4 mg, Cadila Healthcare said in a BSE filing.
The drug will be produced at the group's formulation manufacturing facility at the pharma SEZ in Ahmedabad, it added.
The group now has around 115 approvals from USFDA and has so far filed 300 abbreviated new drug applications (ANDAs), Cadila Healthcare said.
The tablets are used to relieve allergy symptoms such as hives, watery eyes, sneezing and itching eyes or nose, it added.
abbreviated new drug applicationsallergyantihistamineapprovalCadila HealthcareCyproheptadine HydrochlorideU.S. Food and Drug AdministrationUSFDAZydus CadilaSource : PTI