FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression

If approved, SPRAVATO™ will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen’s 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted (14 yes, 2 no, 1 abstain) that data support the favorable benefit-risk profile of SPRAVATOTM (esketamine) nasal spray CIII for adults living with treatment-resistant depression. SPRAVATOTM is an investigational prescription treatment that is thought to work differently than currently approved therapies for major depressive disorder (MDD). Janssen announced on September 4, 2018 that it submitted a New Drug Application (NDA) to the FDA for the approval of SPRAVATOTM.1 If approved, SPRAVATOTM would provide the first new mechanism of action in 30 years to treat this debilitating mental illness.

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The U.S. Food and Drug Administration today approved the first generic of Advair Diskus

The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Mylan obtained approval to market its generic inhaler in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg.

“Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

View the FDA News Release

FDA issues revised draft guidance for MDI and DPI quality considerations

The FDA has issued a revised draft guidance, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations.”

The agency is requesting for written comments to be submitted within 90 days to the Division of Dockets Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The agency advises that all comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. Electronic comments can be submitted to www.regulations.gov.

According to a draft of the Federal Register notice, “The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers, or MDIs) and inhalation powders (also known as dry powder inhalers, or DPIs). The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.”

View the revised draft guidance.