Regulatory

 VistaGen Therapeutics has announced that its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD) has received Fast Track designation from the FDA. The company says that it is preparing to conduct… Read more . . .

Sosei Group has announced that the Ultibro Breezhaler  indacaterol/glycopyrronium DPI has been added to the 2019 National Reimbursement Drug List (NRDL) in China for the treatment of COPD. Novartis launched Ultibro Breezhaler and Seebri Breezhaler in China in… Read more . . .

Hikma Pharmaceuticals announced that it has submitted its response to the FDA’s complete response letter regarding the company’s ANDA for a generic fluticasone propionate/salmeterol DPI. Hikma is partnered with Vectura on the DPI, a generic… Read more . . .

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 . . .