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Regulatory

FDA indicates that Merxin’s MRX004 SMI could be used for generics of Spiriva Respimat

According to a LinkedIn post by generic device maker Merxin, the FDA has indicated that Merxin's MRX004 soft mist inhaler is suitable for an ANDA submission for a generic version of Boehringer Ingelheim's Spiriva Respimat tiotropium bromide SMI. Merxin recently announced that it would sponsor doctoral research at the University of Hertfordshire to support development … [Read more...] about FDA indicates that Merxin’s MRX004 SMI could be used for generics of Spiriva Respimat

Relief Therapeutics acquires AdVita Lifescience, gets orphan drug designation for inhaled aviptadil for sarcoidosis

According to Relief Therapeutics, the FDA has granted orphan drug designation for RLF-100 inhaled aviptadil for the treatment of sarcoidosis; RLF-100 is currently in Phase 2 development for that indication. Relief also recently acquired German company AdVita Lifescience, which has been developing inhaled aviptadil for human and veterinary use, with Relief citing the … [Read more...] about Relief Therapeutics acquires AdVita Lifescience, gets orphan drug designation for inhaled aviptadil for sarcoidosis

NDA for Levo Therapeutics’ intranasal carbetocin for Prader-Willi syndrome gets priority review designation

Levo Therapeutics announced that the FDA has accepted the company's NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger associated with Prader-Willi syndrome (PWS) and has granted the NDA Priority Review designation, with a decision about approval expected by the end of 2021. LV-101 for PWS was granted Fast Track designation by the FDA in 2019. … [Read more...] about NDA for Levo Therapeutics’ intranasal carbetocin for Prader-Willi syndrome gets priority review designation

TGA fines Starpharma more than $93,000 over Viraleze nasal spray claims

The Australian Therapeutic Goods Administration has issued 7 infringement notices to Starpharma regarding advertising of the company's Viraleze astodrimer sodium antiviral nasal spray, with fines totaling $93,240. The news comes shortly after after the UK Medicines and Healthcare products Regulatory Agency questioned claims regarding Viraleze, prompting the company's … [Read more...] about TGA fines Starpharma more than $93,000 over Viraleze nasal spray claims

UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims

According to Starpharma, LloydsPharmacy has paused sales of Starpharma's Viraleze astodrimer sodium antiviral nasal spray after the UK Medicines and Healthcare products Regulatory Agency (MHRA) questioned "promotional claims, including references to SARS-CoV-2 and COVID-19, and the interrelationship between these product claims and its categorization." The company … [Read more...] about UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims

SaNOtize announces Phase 3 study of its nitric oxide nasal spray for COVID-19, new drug submission

SaNOtize Research and Development said that it has gotten approval from Health Canada to move ahead with two Phase 3 trials of its nitric oxide nasal spray for the prevention and treatment of COVID-19. The company also said that it has submitted a new drug submission to the Canadian regulators under a special Health Canada program allowing for rolling review of … [Read more...] about SaNOtize announces Phase 3 study of its nitric oxide nasal spray for COVID-19, new drug submission

Cipla, Glenmark announce final approval for arformoterol tartrate inhalation solution

Cipla and Glenmark Pharmaceuticals have announced that they have received final approval from the FDA for generic versions of Sunovion's Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Cipla said that its product is available immediately. Glenmark noted that the approval is its first for a nebulized product and said that it will … [Read more...] about Cipla, Glenmark announce final approval for arformoterol tartrate inhalation solution

FDA approves Astepro nasal spray for nonprescription use

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 will be the only antihistamine nasal spray for allergies available OTC in the US. The 0.1% strength, which includes pediatric … [Read more...] about FDA approves Astepro nasal spray for nonprescription use

FDA accepts Tyvaso DPI NDA for priority review

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). United Therapeutics submitted the NDA in April 2021, and the agency is expected to complete the … [Read more...] about FDA accepts Tyvaso DPI NDA for priority review

MHRA approves Lupin’s generic of Fostair MDI

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 said. Lupin Limited CEO Vinita Gupta said, "We are truly delighted to receive the first marketing authorization for generic … [Read more...] about MHRA approves Lupin’s generic of Fostair MDI

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