Regulatory

The Chinese National Medical Product Administration (NMPA) has approved an investigative new drug (IND) application for Penthrox methoxyflurane inhaler for two different indications, Medical Developments International (MVP or MDI) has announced. MVP is developing Penthrox… Read more . . .

Levo Therapeutics has announced that the FDA has granted Fast Track designation to its LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS).  In December 2018, Levo said that it was initiating the CARE-PWS… Read more . . .

According to Seelos Therapeutics, the FDA has granted Fast Track designation to its SLS-002 intranasal racemic ketamine for the treatment of acute suicidal ideation and behavior in patients with major depressive disorder. The company also… Read more . . .

On November 1, 2019, Aquestive Therapeutics filed a citizen petition asking the FDA to stay approval of a 505(b)(2) NDA submitted by Neurelis in September 2018 for Valtoco diazepam nasal spray for the treatment of… Read more . . .

After having been notified that CHMP was likely to issue a negative opinion regarding its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis… Read more . . .

According to Aradigm Corporation, the company has been informed that its MAA for Linhaliq dual release inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (NCFBE) is likely… Read more . . .

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Janssen’s Spravato esketamine nasal spray for use with either a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI)… Read more . . .

Janssen Pharmaceutical said that it has submitted a supplemental new drug application to the FDA requesting to expand the use of Spravato esketamine CIII nasal spray for the treatment of major depressive disorder in patients… Read more . . .

GlaxoSmithKline and Innoviva announced that GSK has submitted a supplemental new drug application for the use of the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of asthma. The FDA initially approved Trelegy Ellipta for… Read more . . .