Regulatory
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The FDA announced that it has approved Astepro azelastine hydrochloride nasal spray, 0.15%, for nonprescription use by adults and children aged 6 and older for the treatment of seasonal and perennial allergic rhinitis. Astepro Allergy… Read more . . .
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According to United Therapeutics and MannKind Corporation, the FDA has accepted United Therapeutics’ NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).… Read more . . .
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The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Lupin’s Luforbec beclometasone dipropionate / formoterol fumarate MDI, a generic version of Chiesi’s Fostair MDI, for the treatment of asthma and COPD, the company… Read more . . .
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The FDA is touting its June 1, 2021 approval of Sandoz’s ANDA for an albuterol sulfate MDI for the treatment of asthma, saying, “The FDA recognizes the increased demand for certain products during the COVID-19… Read more . . .
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According to Liquidia, the FDA has accepted the company’s resubmitted NDA for LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension and has set a PDUFA goal date of November 7, 2021. Liquidia initially… Read more . . .
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Inhaler monitoring company Adherium has submitted a 510(k) application for a new Hailie sensor designed to work with the Symbicort MDI the company announced. The company recently rejected a takeover bid from another Australian asthma… Read more . . .
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According to Lannett, the FDA has set a GDUFA goal date of January 31, 2022 for completion of its review of the ANDA for Respirent’s generic version of Advair Diskus fluticasone propionate / salmeterol DPI… Read more . . .
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The EMA’s COVID-19 task force has said “that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19.” In addition, the task force said that “it could not exclude the possibility… Read more . . .
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The UK Ministry of Healthcare Products Regulatory Agency (MHRA) announced that it has approved an application from Aventis Pharma (Sanofi) to reclassify Nasacort Allergy Relief triamcinolone acetonide nasal spray for the treatment of allergic rhinitis in… Read more . . .
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Liquidia has announced the resubmission of its NDA for LIQ861 dry powder treprostinil for the treatment of pulmonary arterial hypertension, with the addition of CMC and device data requested by the FDA. Liquidia initially submitted… Read more . . .
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