Strides Pharma Reaches 9 US OTCs With Naproxen
OTC NDA Approvals Continue As Launch Date Nears For FDA’s Overhauled Monograph Program
Executive Summary
Recent approval of Indian firm’s ANDA for 220-mg naproxen capsules comes as NDA process for launching OTCs in US soon could take a back seat to overhauled monograph program the pharma industry prepares to start using on 1 October.
You may also be interested in...
Strides Founder Back As MD, Asserts Confidence In US As Company Exits Parts Of Europe
Back as Strides managing director, founder Arun Kumar is confident of reversing a slide in profits via a recalibration strategy that saw the company exit Canada and a few European markets. Meanwhile, eyes are on the fallout of a CRO that serviced Strides apart from Sandoz, Teva and more getting caught in CHMP and FDA’s crosshairs.
'Milestone' Discussions With US FDA On OTC Monograph Proposals Limited To One Meeting
Recent draft guidance on scheduling and conducting meetings with FDA supported by OTC monograph user fees largely tracks with agency’s guidance for meetings supported by other user fee programs, such as PDUFA.
Latest Aleve PM Copy Could Have 180-Day Exclusivity From More Competition
US consumers currently don't have access to enough private label/store brand competition for Aleve PM (naproxen/diphenhydramine), FDA decides in granting Apotex its first OTC ANDA approval with Competitive Generic Therapy designation and eligibility for a type of exclusivity unlike any other previously allowed for OTCs.