Regulatory

AstraZeneca has announced that its PT010 budesonide/glycopyrronium/formoterol fumarate MDI has been approved by the Chinese National Medical Products Administration for the treatment of COPD. PT010 was approved in Japan as Breztri Aerosphere in June 2019. According to AstraZeneca, the approval was based on results from the Phase 3 KRONOS trial, which had a primary … [Read more...] about AstraZeneca’s triple combination MDI approved in China for treatment of COPD

According to Evoke Pharma, the company has resubmitted its 505(b)(2) for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. Evoke originally submitted the NDA for Gimoti in in June 2018 and announced that the FDA had issued a complete response letter to that NDA in April 2019. The company said that the resubmitted NDA includes new … [Read more...] about Evoke resubmits NDA for Gimoti nasal spray

Australia's Therapeutic Goods Administration has approved Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of allergic rhinitis and rhinoconjunctivitis, Glenmark Pharmaceuticals said. The marketing application was submitted by Seqirus, which acquired Australian commercialization rights to the nasal spray in July 2018. Glenmark said … [Read more...] about Ryaltris nasal spray approved in Australia

The European Commission has approved Janssen Pharmaceutical's Spravato esketamine nasal spray for the treatment of treatment-resistant major depressive disorder, the company said. The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the MAA for Spravato in October 2019. The FDA approved Spravato for the same … [Read more...] about Spravato approved in Europe

 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 Phase 3 trials of the nasal spray. In September 2018, VistaGen announced that it had acquired exclusive global rights to PH94B from Pherin … [Read more...] about VistaGen’s PH94B nasal spray for social anxiety disorder gets Fast Track designation

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