Trimel Pharmaceuticals has announced the acceptance of its NDA for CompleoTRT bioadhesive intranasal gel testosterone and the PDUFA date, February 28, 2014. The company announced submission of the NDA at the end of April 2013. According to Trimel, CompleoTRT is an intranasal gel with no smell or taste, delivered using a multi-dose applicator, that will eliminate … [Read more...] about Trimel’s NDA for intranasal testosterone product accepted by the FDA
Regulatory
Arikace meets primary endpoint in Phase 3 study
According to Insmed, a Phase 3 study of more than 300 cystic fibrosis patients has demonstrated the non-inferiority of once-daily Arikace inhaled liposomal amikacin to twice-daily TOBI tobramycin inhalation solution, meeting the study's primary endpoint. The company also announced that the FDA has granted Arikace Fast Track and Qualified Infectious Disease Product … [Read more...] about Arikace meets primary endpoint in Phase 3 study
FDA approves Breo Ellipta
The FDA has approved GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol inhalation powder for the treatment of COPD). The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted to recommend approval of Breo Ellipta in April 2013. Theravance will make a $30 million milestone payment to GSK following the approval. The FDA notes that, "The drug … [Read more...] about FDA approves Breo Ellipta
GSK submits NDA for UMEC monotherapy
According to GlaxoSmithKline, the company has submitted an application to the FDA for umeclidinium bromide (UMEC) administered using the Ellipta DPI for the treatment of COPD. The filing comes just days after GSK announced the submission of an MAA in Europe for UMEC monotherapy. The company says that it plans additional filings for the product this year. GSK and … [Read more...] about GSK submits NDA for UMEC monotherapy
Trimel submits NDA for intranasal testosterone to FDA
Trimel Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA regarding its CompleoTRT bioadhesive intranasal gel testosterone for the treatment of testosterone deficiency in men. According to the company, the intranasal gel is fully absorbed within half and hour and would avoid the potential transference problems presented by topic gel products. … [Read more...] about Trimel submits NDA for intranasal testosterone to FDA
GSK submits EU regulatory application for UMEC monotherapy
GlaxoSmithKline says that it has submitted a Marketing Authorisation Application (MAA) to the EMA for umeclidinium bromide (UMEC) monotherapy to be delivered using the Ellipta DPI for the treatment of COPD. UMEC is a long-acting muscarinic antagonist (LAMA). GSK and Theravance recently submitted an application in Japan for the Anoro Ellipta UMEC/vilanterol inhaler, … [Read more...] about GSK submits EU regulatory application for UMEC monotherapy
Anoro Ellipta application submitted in Japan
GlaxoSmithKline and Theravance have submitted an application for the Anoro Ellipta umeclidinium bromide /vilanterol (UMEC/VI) DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare (MHLW), the companies said. The submission in Japan is for 62.5/25mcg and 125/25mcg doses of UMEC/VI. In the US, the Anoro Ellipta has a PDUFA date of … [Read more...] about Anoro Ellipta application submitted in Japan
FDA advisory committee recommends approval of Breo Ellipta
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of of GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of COPD. The PADAC meeting had been rescheduled from an earlier date due to weather. During the rescheduled meeting on April 17, the committee voted in favor of approval … [Read more...] about FDA advisory committee recommends approval of Breo Ellipta
Allergan acquires Exemplar, gets Complete Response Letter for Levadex
Allergan, which recently acquired MAP Pharmaceuticals, has announced that it has received a Complete Response Letter (CRL) from the FDA in regard to its NDA for Levadex inhaled dihydroergotamine for the treatment of migraines. The company also announced that it has acquired CMO Exemplar, which had previously received a form 483 for problems with Levadex … [Read more...] about Allergan acquires Exemplar, gets Complete Response Letter for Levadex
Discovery Labs says Aerosurf program “currently remains on track”
According to Discovery Laboratories its Aerosurf aerosolized surfactant development program "currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013" and is unaffected by the FDA's recent questions about product specifications for Discovery Labs' Surfaxin intratracheal suspension surfactant. The company says that it will respond to … [Read more...] about Discovery Labs says Aerosurf program “currently remains on track”