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GlaxoSmithKline PLC

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Latest From GlaxoSmithKline PLC

With Novel NRT Proposal, GSK Includes Novel Labeling: 'Quick Start Guide'

Results of both its clinical trials showed significantly higher rates of smoking abstinence, but GSK adds first labeling for an NRT formatted as a Quick Start Guide and makese other label changes "to further assist consumers in how to use the spray dispenser." Similarity of mouth spray formulation's safety profile to other OTC NRTs is a key point in GSK's proposal.

OTC Drugs Advisory Committees

'Naturalistic' Trial In GSK's Nicotine Mouth Spray NDA Historic For OTC NRTs

What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.

OTC Drugs FDA

Deal Watch: Castle Creek Likes Partner Fibrocell Enough To Buy It

Dermatology-focused regenerative medicine firm Fibrocell has been reviewing strategic opportunities for more than a year; April’s FCX-007 license deal with Castle Creek results in buyout.

Deals Business Strategies

GSK Proposal For Novel Delivery NRT Leaves FDA Doubting 'Real World' Efficacy

In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."

OTC Drugs FDA
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