The FDA has 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 […]
Sleep Pharmaceuticals
On-Road Driving Safety Study of Investigational Lemborexant Published in SLEEP®
Eisai Co., Ltd. and Purdue Pharma L.P. recently announced the publication of a Phase 1 safety study evaluating the impact of bedtime administration with lemborexant on driving performance the following morning. The study, which met its primary endpoint, showed no statistically significant next-day impairment of driving performance in healthy adult and […]
Cook Medical to Market Min-Inv Treatment for Snoring
Cook Medical and Zelegent, Inc. announced an agreement to enhance treatment options for patients suffering from snoring. Working together, the two companies will market Zelegent’s new minimally invasive technology for snoring. The Elevo® Kit Snoring Intervention Device allows physicians to perform Elevoplasty® in an office-based setting with no general anesthesia. Headquartered in […]
FDA Approves Teva’s ProAir Digihaler, First and Only Digital Inhaler
Teva Pharmaceutical Industries Ltd. announced that the FDA has approved ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir® Digihaler™ is indicated for the treatment […]
Jazz Receives New PDUFA Goal Date for Solriamfetol for EDS Associated with Narcolepsy or OSA
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The updated Prescription Drug User […]
FDA Approves Genentech’s Xolair Prefilled Syringe Formulation
The 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes are expected to be available by the end of 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 […]
Promising Data for First New Narcolepsy Drug in Ten Years, Pending Approval
Platform presentation highlights open-label, long-term safety and tolerability results, durability of effect over time in both EDS and cataplexy in patients with narcolepsy Harmony Biosciences, LLC (Harmony) recently presented new data on pitolisant at the 7th International Symposium on Narcolepsy in Beverly, MA. Pitolisant is an investigational product that has […]
Sunovion First To Offer Nebulized Long-Acting Muscarinic Antagonist (LAMA) For COPD In The U.S.
Sunovion Pharmaceuticals Inc. (Sunovion) today announced that Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily) is now available at pharmacies in the U.S. for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. LONHALA MAGNAIR is the first […]
Could Cannabis Be The Answer To Some Sleep Disorders?
Millions of people who suffer from some form of insomnia. Whether it be brief symptoms or chronic, not getting the recommended amount of sleep is something that can affect everyday life. Lack of sleep can cause lower productivity and could be dangerous. CURE Pharmaceutical is working on a way to […]
Sunovion Receives FDA Approval for Lonhala™ Magnair™ Inhalation Solution to Treat COPD
Sunovion Pharmaceuticals Inc. today announced that the FDA approved the New Drug Application (NDA) for Lonhala™ Magnair™ (glycopyrrolate) Inhalation Solution (25 mcg twice daily), also known as SUN-101/eFlow®, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Sunovion […]













