1. Scrip
  2. >>New Products

Dermira Wins First FDA Approval, Preps Qbrexza For October Launch In Hyperhidrosis

 
• By Mandy Jackson

The company shifted attention in March from its big acne setback to its mid-year Qbrexza approval, so with a recent FDA nod for the hyperhidrosis treatment, Dermira will fill out its sales team and make the topical product for excessive underarm sweating available in October.

Diagnosis - Hyperhidrosis. Medical Concept with Blurred Text, Stethoscope, Pills and Syringe on Green Background. Selective Focus. 3D Render.

Dermira Inc. claimed an important victory when it won US FDA approval for Qbrexza (glycopyrronium) – a topical anticholinergic delivered by a cloth wipe – on June 29 for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients aged 9 and older.

The agency's decision marks the company's first-ever drug approval and it provided the Menlo Park, Calif., company with a needed...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

PTC Projects Confidence In Sephience Launch With Royalty Buyback

 
• By Manas Mishra

The company will start shipping its newly launched phenylketonuria drug within two weeks and has bought back global net sales obligations for the treatment.

Jazz’s Modeyso Approved For Rare Glioma With Expansion Targeted

 
• By Jessica Merrill

The accelerated approval came three months after Jazz completed the acquisition of Modeyso’s developer, Chimerix.

S&E In Brief: Launch Trends And Regulatory Updates Among SMID Biopharmas

 
• By Jessica Merrill

Ultragenyx updated investors on interactions with the US FDA on gene therapy, while new drug launches were themes for Ionis and Organon in Q2 reporting.

Pipeline Watch: Ten Approvals And Fourteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

PTC Projects Confidence In Sephience Launch With Royalty Buyback

 
• By Manas Mishra

The company will start shipping its newly launched phenylketonuria drug within two weeks and has bought back global net sales obligations for the treatment.

Executives On The Move: Changes At The Top At Novo Nordisk Plus Other New CEOs

Flashpoint Therapeutics and Nerviano Medical Sciences (Shanghai) have new leaders, while Genmab hires an ex-Gilead Sciences executive.

Lilly Confident In Orforglipron Despite Disappointing Phase III Data

 
• By Mandy Jackson

Lilly spent much of its earnings call defending orforglipron as analysts lamented its results in obesity versus Novo’s semaglutide, overshadowing strong Q2 revenue growth driven by existing GLP-1/GIP franchise Mounjaro/Zepbound.