OINDPnews


Aptar Pharma banner

Regulatory

FDA tentatively approves Liquidia’s NDA for Yutrepia treprostinil DPI

According to Liquidia, the FDA has tentatively approved the company's NDA for its Yutrepia (LIQ861) treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The FDA had previously issued a complete response letter to the NDA in November 2020. Liquidia refiled the LIQ861 NDA in May 2021, and in August 2021, the agency completed a pre-approval … [Read more...] about FDA tentatively approves Liquidia’s NDA for Yutrepia treprostinil DPI

Switzerland approves Bronchitol DPI as an add-on to other CF medications

According to EffRx Pharmaceuticals, Swissmedic has approved Bronchitol inhaled dry powder mannitol as an add-on to other medications for the treatment of cystic fibrosis in patients 6 years old and older. EffRx acquired Swiss rights to Bronchitol from Pharmaxis in 2019. The company said that it expects to launch the DPI in Switzerland in the second half of … [Read more...] about Switzerland approves Bronchitol DPI as an add-on to other CF medications

Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide

According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF's dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers in the SAD phase and 3 and 6 mg doses twice a day for 5 days in the MAD phase. TFF said that it expects dosing to get underway in November 2021 and … [Read more...] about Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide

FDA approves Oyster Point’s Tyrvaya nasal spray for the treatment of dry eye disease

According to Oyster Point Pharma, the FDA has approved the company's Tyrvaya (OC-01) varenicline nasal spray for the treatment of dry eye disease, and Oyster Point expects to launch the nasal spray in November 2021. Oyster Point submitted the 505(b)(2) NDA for OC-01 in December 2020 and announced that the FDA accepted the NDA in March 2021. The company had previously … [Read more...] about FDA approves Oyster Point’s Tyrvaya nasal spray for the treatment of dry eye disease

Bayer and Meda file patent infringement suit after Apotex submits ANDA for generic of Astepro Allergy nasal spray

Bayer HealthCare and Meda Pharmaceuticals have filed a patent infringement suit against Apotex after Apotex submitted an ANDA for a generic version of Astepro Allergy azelastine hydrochloride nasal spray, 0.15%. The FDA approved Bayer's NDA for Astepro Allergy for non-prescription treatment of allergic rhinitis in June 2021. According to the complaint filed by Bayer … [Read more...] about Bayer and Meda file patent infringement suit after Apotex submits ANDA for generic of Astepro Allergy nasal spray

Ryaltris nasal spray gets marketing approval in 13 countries in Europe, UK

Glenmark Pharmaceuticals said that its Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis has received final marketing approval in 13 countries in Europe and the UK. Earlier this year, the company announced that Ryaltris had received approval in 16 European countries and the UK through the decentralized … [Read more...] about Ryaltris nasal spray gets marketing approval in 13 countries in Europe, UK

BreatheSuite MDI monitoring system gets 510(k) clearance

BreatheSuite announced that the FDA has cleared the company's disposable BreatheSuite MDI device, which attaches to the top of a standard metered dose inhaler canister to provide inhaler usage monitoring and feedback to the patient and to health care providers through an associated mobile app. According to BreatheSuite, the device has also been cleared by Canadian … [Read more...] about BreatheSuite MDI monitoring system gets 510(k) clearance

Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities

According to Ampio Pharmaceuticals, the Drugs Controller General of India (DCGI) has approved the protocol for AP-019 Phase 2 trial of the company's inhaled Ampion biologic for the treatment of respiratory distress caused by COVID-19. Ampio announced in June 2021 that it had initiated the Phase 2 AP-019 clinical trial in the US and noted that the FDA had approved … [Read more...] about Phase 2 trial of inhaled Ampion for COVID-19 gets approval from Indian authorities