Regulatory
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Hovione has announced that the FDA has found its Loures, Portugal manufacturing site to be GMP compliant, although the agency issued a Form 483 citing three inspectional observations. The inspection took place from December 1… Read more . . .
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PulmoFlow has announced that the FDA has approved its NDA for Kitabis Pak, generic tobramycin inhalation solution packaged with a PARI LC PLUS nebulizer, for the treatment P. aeruginosa infections in cystic fibrosis patients. PARI… Read more . . .
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Meda Pharmaceuticals and Cipla have filed suit against Apotex in the Delaware Federal District Court, claiming that Apotex’s submission of an ANDA for a generic version of Dymista azelastine HCl/fluticasone propionate nasal spray violates patents… Read more . . .
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According to Avanir Pharmaceuticals, it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for AVP-825 intranasal sumatriptan for the treatment of migraine. The company had recently warned… Read more . . .
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According to Bayer, its Amikacin Inhale inhalation solution and its ciprofloxacin DPI have both been granted qualified infectious disease product (QIDP) designation by the FDA. Both products are currently in Phase 3 development. Bayer HealthCare… Read more . . .
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According to AstraZeneca, the European Commission has approved the Duaklir Genuair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the product… Read more . . .
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According to Sandoz, Ireland and the Czech Republic have approved marketing applications for the AirFluSal Forspiro salmeterol/fluticasone DPI in 50-250 and 50-500 µg dosage forms for the treatment of asthma and/or COPD. The Czech approval… Read more . . .
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According to Avanir Pharmaceuticals,the FDA has issued a Discipline Review letter in response to the company’s NDA for AVP-825 intranasal dry powder sumatriptan requesting that the company “optimize the product-user interface” and conduct additional human… Read more . . .
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Accordig to Sandoz, the company has received marketing authorization in Estonia, Latvia and Lithuania for the 50-250 and 50-500 µg dosages of the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD. The… Read more . . .
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FSC Laboratories has announced that its Flexichamber collapsible valved holding chamber has received FDA clearance for use with most pMDIs. The device, which can be used with or without a mask, will be available by… Read more . . .
Upcoming Events
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May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan