Regulatory

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 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

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

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

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

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 public health emergency and has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with … [Read more...] about FDA approves Sandoz albuterol MDI

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 submitted the 505(b)(2) NDA in January 2020; the agency accepted the submission in April 2020 and then issued a complete response letter to the … [Read more...] about FDA accepts Liquidia’s NDA resubmission for LIQ861 dry powder treprostinil

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 for the treatment of asthma and COPD. The submission of the ANDA was announced in April 2021 by Lannett, which acquired US rights to the generic version of … [Read more...] about FDA sets goal date for review of Lannet’s ANDA for generic of Advair Diskus