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
Regulatory
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The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers.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 The draft guidance notes that if the reference … [Read more...]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
PMCPA reprimands Chiesi for misleading claims about Fostair
The UK's Prescription Medicines Code of Practice Authority (PMCPA) has reprimanded Chiesi for a misleading and unsubstantiated claim regarding the company's Fostair beclometasone/formoterol inhaler. The authority has published advertisements in the BMJ, The Pharmaceutical Journal, and The Nursing Standard that say, "The Code of Practice Panel reported the company to … [Read more...] about PMCPA reprimands Chiesi for misleading claims about Fostair
Insmed confirms filing of MAA for Arikayce, announces new hires
In its announcement of fourth quarter and full year financial results for 2014, Insmed has confirmed that it filed an MAA for Arikayce liposomal amikacin inhalation solution. The company said that the EMA's Pediatric Committee has approved the Pediatric Investigation Plan for the product, and the MAA has subsequently been validated. Insmed also announced the … [Read more...] about Insmed confirms filing of MAA for Arikayce, announces new hires
TGA warns of smoking devices that look nearly identical to MDIs
Australia's Therapeutic Goods Administration (TGA) has issued a warning about devices marketed by a company called Discreet Vape that look nearly identical to metered dose inhalers used for rescue medications for asthma. The PUFFiT and PUFFiT-X devices are advertised as "the discreet choice" for smoking "dry herbal blends." Discreet Vape, based in Hong Kong, … [Read more...] about TGA warns of smoking devices that look nearly identical to MDIs
Meda’s Dymista gets FDA approval for children aged 6-11
The FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis in children aged 6-11 "who require treatment with both components," the company said. Dymista was approved for adults and for children 12 and older in 2012. Meda submitted data from two pediatric trials to support the … [Read more...] about Meda’s Dymista gets FDA approval for children aged 6-11
Adapt Pharma gets Fast Track designation for intranasal naloxone
The FDA has granted Adapt Pharma Fast Track designation for its intranasal naloxone for the treatment of opioid overdose, the company said. Adapt Pharma licensed the product from Lightlake Therapeutics in December 2014. In the same month, Lightlake began a new trial of the drug for the opiod overdose reversal indication. Funding for the trial has been provided by the … [Read more...] about Adapt Pharma gets Fast Track designation for intranasal naloxone