Regulatory
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Italian startup Plumestars has announced via Twitter that it has received orphan drug status from the EMA for its amikacin dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. Here… Read more . . .
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Accoding to Teva, the FDA has approved the company’s QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis symptoms in children aged 4-11. The supplemental NDA for the pediatric product was accepted… Read more . . .
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According to Insmed, the company has filed an MAA for its Arikayce liposomal amikacin for inhalation, and it has been informed by the EMA that the only remaining issue, a review of the Pediatric Investigation… Read more . . .
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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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