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Regulatory

FDA approves Alembic’s generic formoterol fumarate inhalation solution

The FDA has approved Alembic Pharmaceuticals' ANDA for its formoterol fumarate inhalation solution, a generic of Mylan's Perforomist inhalation solution for the treatment of COPD, the company said. According to the announcement, this is the company's first US approval for an inhaled product. Alembic said that it worked with Indian contract research organization … [Read more...] about FDA approves Alembic’s generic formoterol fumarate inhalation solution

FDA clears IND for Phase 2 study of Tonix’s intranasal oxytocin for the prevention of migraine

According to Tonix Pharmaceuticals, the FDA has cleared the company's IND for a Phase 2 study of TNX-1900 potentiated oxytocin nasal spray for the prevention of migraine headache. Tonix acquired the rights to the intranasal oxytocin for the treatment of migraine from Trigemina in June 2020 and says that it would plan to submit an NDA under the 505(b)(2) pathway. Over … [Read more...] about FDA clears IND for Phase 2 study of Tonix’s intranasal oxytocin for the prevention of migraine

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