Kyorin Pharmaceutical has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved its marketing application for the Eklira Genuair aclidinium bromide DPI for the treatment of COPD in 30 and 60 inhalation versions. Kyorin licensed Eklira Genuair from Almirall in February 2011. The company also markets SkyePharma's Flutiform … [Read more...] about Eklira Genuair approved in Japan
Regulatory
ProAir RespiClick gets FDA approval
The FDA has now approved Teva's ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 12 and older, the company said. Teva had announced tentative approval of the product, which was previously known as ProAir Spiromax, on March 5, 2015. Teva Senior VP, Global Respiratory R&D, Tushar Shah commented, "Teva is committed to optimizing … [Read more...] about ProAir RespiClick gets FDA approval
Encruse Ellipta approved in Japan
According to GSK, the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved its Encruse Ellipta umeclidinium DPI for the treatment of COPD, and the company plans to launch the product in Japan sometime this year. The approved dosage is 62.5 mcg. GSK announced in May 2014 that it had filed the application for the inhaler, which is approved in the US … [Read more...] about Encruse Ellipta approved in Japan
Invion announces successful pre-IND meeting with FDA for inhaled nadolol
According to Invion Limited, the company "has received a positive response" from the FDA during a pre-IND meeting regarding its INV102 inhaled nadolol for the treatment of asthma and COPD. Invion is developing the drug in partnership with 3M Drug Delivery Systems, and the company said that the agency has accepted both the formulation and proprietary MDI technology … [Read more...] about Invion announces successful pre-IND meeting with FDA for inhaled nadolol
FDA advisory committes vote to recommend Breo Ellipta for asthma in adults 18 and over
The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee have voted 16-4 to recommend the approval of GSK's Breo Ellipta fluticasone/vilanterol DPI for the treatment of asthma in patients 18 and older. The FDA approved Breo Ellipta for the treatment of COPD in May 2013, and GSK submitted a supplemental NDA … [Read more...] about FDA advisory committes vote to recommend Breo Ellipta for asthma in adults 18 and over
FDA releases Sunovion from further postmarket studies of Xopenex
In a letter from the FDA to Sunovion dated March 12, 2015, the agency informed the company that all postmarketing requirements and commitments specified after the 2005 approval of the Xopenex HFA levalbuterol MDI have been completed. A labeling change regarding the use of Xopenex HFA in children less than four years old was also approved. The agency accepted the … [Read more...] about FDA releases Sunovion from further postmarket studies of Xopenex
Kitabis Pak rated as a therapeutic equivalent of TOBI by the FDA
The FDA has listed PARI's Kitabis Pak in the Orange Book as a therapeutic equivalent of Novartis's TOBI tobramycin inhalation solution with an AN rating, PARI has announced. Kitabis Pak, tobramycin inhalation solution packaged with a PARI nebulizer, was approved by the FDA for the treatment of P. aeruginosa infections in cystic fibrosis patients in December 2014. … [Read more...] about Kitabis Pak rated as a therapeutic equivalent of TOBI by the FDA
Indian patent office revokes Spiriva patent
The Indian patent office has revoked a Boehringer Ingelheim patent for Spiriva on grounds that "applicant have failed to establish any technical advancement or any economic significance of the compound Tiotropium bromide monohydrate over the disclosures of prior art" and that it is not patentable under section 3(d) of the Patents Act. The BI patent, titled … [Read more...] about Indian patent office revokes Spiriva patent
Teva gets tentative approval for the ProAir RespiClick albuterol DPI
The FDA has tentatively approved Teva's ProAir RespiClick albuterol dry powder inhaler as of March 5, 2015. Teva filed an NDA for an albuterol "MDPI" (multi-dose dry powder inhaler) for the treatment of asthma in July 2014. At the time, it referred to the product as "ProAir Spiromax." The company applied for a trademark on the name "ProAir RespiClick" in an … [Read more...] about Teva gets tentative approval for the ProAir RespiClick albuterol DPI
FDA issues draft BE guidance for ipatropium bromide MDIs
The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers. In the US, Boehringer Ingelheim markets its ipatropium MDI for the treatment of COPD under the brand name Atrovent. The recommended tests included five in vitro tests, a PK study, and a PD study. The draft guidance notes that if the reference … [Read more...] about FDA issues draft BE guidance for ipatropium bromide MDIs