Regulatory

The FDA has approved Evoke Pharma's Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, the company said. Evoke originally submitted an NDA for Gimoti in in June 2018 and acknowledged receipt of a complete response letter to that NDA in April 2019. The company resubmitted the NDA in December 2019. In January 2020, Evoke announced that it … [Read more...] about Gimoti metoclopramide nasal spray approved by the FDA

DPI developer TFF Pharmaceuticals said that the FDA has granted orphan drug designation to its dry powder tacrolimus for the prevention of lung transplant rejection. The company also said that it plans to initiate a Phase 1 SAD study of the tracrolimus inhalation powder this month followed by a MAD study in the third quarter of this year. TFF President and CEO … [Read more...] about TFF gets orphan drug designation for inhaled tacrolimus for prevention of lung transplant rejection

The FDA has issued new and revised product-specific guidances (PSGs) for a number of OINDPs as of June 3, 2020. The agency also updated its list of planned PSGs for complex generics, adding a number of PSGs for OINDPs to that list. New PSGs issued on June 3 include: Glycopyrrolate/indacaterol maleate inhalation powderRevefenacin inhalation solution Revised … [Read more...] about FDA issues additional product-specific guidances for OINDPs

Microbion Corporation said that its pravibismane inhalation suspension for the treatment of lung infections in patients with cystic fibrosis has been granted orphan drug designation by the FDA. Pravibismane inhalation suspension has already been granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for that indication. According to the … [Read more...] about Microbion gets orphan designation for pravibismane inhalation suspension for lung infections in CF patients

Cipla said that it has received final approval for an ANDA for its generic version of Bausch's Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company's first FDA approval for a generic nasal spray; the agency has recently approved an ANDA for Cipla's generic Proventil HFA. The FDA approved the … [Read more...] about FDA approves Cipla’s generic of Migranal DHE nasal spray with CGT designation

The Chinese National Medical Products Administration (NMPA) has approved AstraZeneca's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. AstraZeneca's Breztri Aerosphere budesonide/glycopyrronium/formoterol fumarate MDI was approved for the treatment of COPD by the NMPA in December 2019. In June 2019, Bevespi … [Read more...] about Bevespi Aerosphere approved in China for the treatment of COPD