FDA Panel Denies Aradigm the Opportunity to Market Inhaled Antibiotic Treatment for Non-Cystic Fibrosis Bronchiectasis Patients

Posted by on January 29, 2018

The Antimicrobial Drugs Advisory Committee (AMDAC) convened on January 11th, 2018 to discuss new drug application 210693, ciprofloxacin dispersion for inhalation (LINHALIQ), sponsored by Aradigm Corp. The panel discussed the proposed indication of treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa. Aradigm has since received a complete response letter
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FDA Panel Rejects Philip Morris’ Claim that iQOS Device is Safer than Continuing to Smoke Cigarettes

Posted by on January 26, 2018

The Tobacco Products Scientific Advisory Committee met on January 24th and 25th, 2018 to discuss the modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for iQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks. These modified-risk applications are different from
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FDA Panel Denies Clarus and Lipocine a Run at the First Oral Testosterone Replacement Therapy

Posted by on January 16, 2018

The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) met on January 9th and 10th to discuss two potential oral testosterone formulations: Jatenzo (Clarus Therapeutics) and Tlando (Lipocine). Both formulations are the first proposed oral testosterone replacement therapy for males with conditions associated with a deficiency or absence of testosterone, such as congenital/acquired primary hypogonadism
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FDA Panel Conducts Safety Review of Gadolinium Retention in the Brain from Gadolinium Based Contrast Agents

Posted by on November 27, 2017

On September 8th, the Medical Imaging Drugs Advisory Committee (MIDAC) discussed the potential risk of systemic gadolinium retention, especially in the brain, in patients receiving gadolinium-based contrast agents (GBCAs) used for magnetic resonance imaging (MRI) diagnostic procedures. This was a multi-sponsor meeting, which included Bayer Healthcare, Bracco Diagnostics, GE Healthcare, and Guerbet. The meeting began
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FDA Advisory Committee Votes Negatively on Safety and Effectiveness of Bayer’s Ciprofloxacin Inhalation Powder

Posted by on November 27, 2017

The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) convened on November 16th to discuss ciprofloxacin inhalation powder (NDA 209367), sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis (CF) bronchiectasis (NCFB) in adult patients (≥18 years of age) with respiratory bacterial pathogen. Ciprofloxacin is a synthetic, fluorinated carboxyquinolone
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FDA Advisory Committee Makes Recommendations for Pfizer Staph Vaccine Trial

Posted by on November 26, 2017

On November 7th, the Vaccines and Related Biological Products Committee (VRBPAC) met to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine (SA4Ag) intended for pre-surgical prophylaxis in elective orthopedic surgical populations. Specifically, the FDA sought the committee’s input regarding the clinical data necessary to support the indication. The
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FDA Advisory Committee Recommends Approval of Two Buprenorphine Products for the Treatment of Opioid Use Disorder

Posted by on November 25, 2017

The Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) convened on October 31st and November 1st to discuss two buprenorphine subcutaneous injections for treatment of opioid dependence. On October 31st the joint committee discussed buprenorphine subcutaneous injection (RBP-600; NDA 209819), submitted by Indivior Pharmaceuticals, Inc. and on the
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FDA Advisory Committee Recommends Approval of Novo Nordisk’s Type 2 Diabetes Drug, Semaglutide

Posted by on November 24, 2017

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on October 18th, to discuss the safety and efficacy of semaglutide injection (NDA 209637) submitted by Novo Nordisk. The proposed indication is to improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise. The committee first discussed the
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FDA Advisory Committee Votes in Favor of Rhopressa™

Posted by on November 23, 2017

On October 13th, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) discussed the new drug application (NDA 208254) for Rhopressa™ (netarsudil ophthalmic solution) 0.02%, submitted by Aerie Pharmaceuticals Inc. The proposed indication for Rhopressa is to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). There were 2 voting
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FDA Advisory Committee Unanimously Votes in Support of the Approval of GSK Shingles Vaccine

Posted by on November 22, 2017

The FDA’s Vaccines and Related Biological Products Committee (VRBPAC) met on September 13th to discuss and make recommendations on the safety and effectiveness of Zoster Vaccine Recombinant (Adjuvanted) -Shingrix™, manufactured by GlaxoSmithKline Biologicals (GSK). The committee voted unanimously (11 Yes, 0 No, 0 Abstain) that the data was adequate to support both the safety and
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