Regulatory

Evoke Pharma has submitted a 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, the company said. Earlier this year, Evoke announced that it had amended its deal with Mallinckrodt to defer milestone payments due on acceptance of review of the Gimoti NDA on final approval, with a single … [Read more...] about Evoke submits NDA for Gimoti metoclopramide nasal spray for diabetic gastroparesis

GSK Australia has announced that the Australian Pharmaceutical Benefits Scheme (PBS) will reimburse for Trelegy Ellipta for the treatment of moderate to severe COPD as of June 1, 2018. According to a document on the Therapeutic Goods Administration (TGA) website, Trelegy Ellipta was entered into the Australian Register of Therapeutic Goods as of January 16, 2018. … [Read more...] about Australian Pharmaceutical Benefits Scheme to reimburse for Trelegy Ellipta

GSK and Innoviva have announced that an NDA for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW). Trelegy Ellipta was approved in the US and in Europe for the treatment of COPD in 2017 and was approved in Canada earlier this year. The FDA … [Read more...] about GSK submits marketing application for Trelegy Ellipta in Japan

Indian pharma company Sava Healthcare has announced that its DPI capsule manufacturing line has received approval from the Russian Ministry of Health (MOH). Sava said that it manufactures tiotropium, formoterol, salmeterol/fluticasone, and budesonide/formoterol DPIs for the Russian and CIS markets. According to Sava, its Surendranagar facility, which also … [Read more...] about Sava Healthcare gets Russian GMP approval for Indian DPI capsule manufacturing line

Glenmark Pharmaceuticals has submitted an NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in patients aged 12 and older, the company said. In December 2017, the company announced that a Phase 3 trial of Ryaltris (GSP 301) had met its primary endpoint. Glenmark Pharmaceuticals President … [Read more...] about Glenmark submits NDA for Ryaltris nasal spray

According to GSK, the FDA has approved the company's sNDA for the use of Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11 years. Arnuity Ellipta was approved by the FDA in 2014 for the treatment of asthma in patients 12 years old and older. GSK submitted the sNDA for pediatric use in July 2017. The new approval is for a … [Read more...] about FDA approves Arnuity Ellipta for pediatric use

The FDA has accepted Insned's NDA for ALIS (amikacin liposome inhalation suspension) for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), with a PDUFA date of September 28, 2018, the company said. Insmed announced submission of the NDA in March 2018. Insmed President and CEO Will Lewis commented, "We … [Read more...] about Insmed’s NDA for ALIS accepted by the FDA

The FDA informed Perrigo during a May 10, 2018 teleconference that the agency will issue a complete response letter to the company's ANDA for its generic version of Teva's ProAir albuterol MDI, Perrigo said. As a result, the company no longer expects to launch its albuterol inhaler by the end of 2018. Perrigo filed an ANDA for the generic version of ProAir in … [Read more...] about Perrigo expects CRL for albuterol MDI ANDA