Regulatory

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… Read more . . .

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… Read more . . .

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… Read more . . .

The FDA has issued a draft guidance on the establishment of bioequivalence for ipatropium bromide metered dose inhalers.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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .