Regulatory

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 March 2019. Sosei Heptares President and CEO Shinichi Tamura commented, "We are pleased that COPD patients … [Read more...] about Ultibro Breezhaler added to National Reimbursement Drug List in China

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 version of Advair Diskus known as VR315US. The FDA issued the CRL in May 2017. In March 2018, Hikma announced that the agency … [Read more...] about Hikma submits response to FDA for its generic of Advair Diskus

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 in China for trauma pain and for procedural pain. The company said that it plans to complete … [Read more...] about Chinese regulators approve IND for Penthrox

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 Phase 3 study of LV-101 for PWS; the company says that the study is currently enrolling participants. The company also said that it has … [Read more...] about Levo’s intranasal carbetocin for PWS gets Fast Track designation

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 said that it expects data from a Phase 1 study of SLS-002 in early 2020. In October 2019, Seelos announced that it had amended … [Read more...] about Seelos gets Fast Track designation for its intranasal racemic ketamine

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 cluster seizures in epilepsy. Aquestive, which is developing a diazepam buccal oral film for the treatment of breakthrough seizures, says the agency … [Read more...] about Aquestive files citizen petition asking FDA to delay approval of Valtoco nasal spray

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 bronchiectasis (NCFBE), Aradigm has withdrawn the application. The company initially submitted the MAA in March 2018. Aradigm filed for … [Read more...] about Aradigm withdraws Linhaliq MAA

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 to receive a negative opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). CHMP is scheduled to … [Read more...] about Aradigm says Linhaliq likely to receive negative opinion from CHMP

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) for the treatment of treatment-resistant major depressive disorder, the company said. A final decision by the … [Read more...] about Janssen’s Spravato esketamine nasal spray gets positive opinion from CHMP