Hikma Pharmaceuticals announced that the FDA has approved 100 mcg/50 mcg and 250 mcg/50 mcg doses of the company's fluticasone propionate / salmeterol DPI (VR315), a generic version of Advair Diskus and that the company has launched the inhaler in the US. The FDA had issued a minor CRL in response to the ANDA in September 2020. A previous CRL had been issued in May … [Read more...] about Hikma gets FDA approval for, and launches, generic version of Advair Diskus
Regulatory
Trixeo Aerosphere approved by EU for the treatment of COPD
The EU has approved AstraZeneca’s Trixeo Aerosphere (PT010) formoterol fumarate / glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination, the company said. The EMA's CHMP had adopted a positive opinion regarding the MAA for Trixeo Aerosphere in October … [Read more...] about Trixeo Aerosphere approved by EU for the treatment of COPD
Codagenix and SIIPL initiate Phase 1 trial of COVI-VAC intranasal vaccine
Codagenix and vaccine manufacturer Serum Institute of India (SIIPL) have initiated a Phase 1 trial of COVI-VAC single-dose intranasal, live attenuated vaccine against SARS-CoV-2 after receiving approval from the MHRA, the companies said. Like Codagenix's CodaVax-RSV vaccine, which is also in Phase 1 development, COVI-VAC is based on Codagenix's SAVE codon … [Read more...] about Codagenix and SIIPL initiate Phase 1 trial of COVI-VAC intranasal vaccine
CHMP adopts positive opinion regarding expanded indication for Spravato
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding an expanded indication for Janssen's Spravato esketamine nasal spray on December 10, 2020. The proposed revision would add the use of Spravato "as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement … [Read more...] about CHMP adopts positive opinion regarding expanded indication for Spravato
United Therapeutics gets orphan drug designation for treprostinil for the treatment of IPF
According to United Therapeutics, the FDA has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with the designation's benefits applying to both Tyvaso inhalation solution and Treprostinil Technosphere dry powder treprostinil. United Therapeutics also said that the FDA has cleared the company's IND … [Read more...] about United Therapeutics gets orphan drug designation for treprostinil for the treatment of IPF
AireHealth gets 510(k) clearance for connected nebulizer
According to Florida-based startup AireHealth, the company has received 510(k) clearance from the FDA for its VitalMed connected portable vibrating mesh nebulizer. Earlier this year, AireHealth acquired BreathResearch and its VitalBreath virtual respiratory health monitoring platform. In 2021, the company said, the VitalMed nebulizer will connect to a new app called … [Read more...] about AireHealth gets 510(k) clearance for connected nebulizer
ARS submits MAA for Neffy epinephrine nasal spray
According to ARS Pharmaceuticals, the EMA has accepted the company's marketing authorization application for its Neffy (ARS-1) epinephrine nasal spray for the emergency treatment of anaphylaxis. ARS recently announced that Recordati had acquired marketing rights to ARS-1 in the EU, Iceland, Liechtenstein, Norway, Switzerland, the UK, Russia/CIS, Turkey, the Middle … [Read more...] about ARS submits MAA for Neffy epinephrine nasal spray
Altimmune submits IND for AdCOVID nasal vaccine
Altimmune announced that it has submitted an investigational new drug application to the FDA for a Phase 1 clinical study of its AdCOVID intranasal COVID-19 vaccine candidate, which it is developing in partnership with the University of Alabama Birmingham. The company recently announced that it had signed an agreement with Lonza for manufacturing of … [Read more...] about Altimmune submits IND for AdCOVID nasal vaccine
Liquidia gets CRL for LIQ861 treprostinil DPI
Liquidia Technologies said that it has received a complete response letter in response to its NDA for LIQ861 treprostinil inhalation powder for the treatment of pulmonary arterial hypertension. The FDA accepted the 505(b)(2) NDA for review in April 2020. According to Liquidia, the letter cites "the need for additional information and clarification on chemistry, … [Read more...] about Liquidia gets CRL for LIQ861 treprostinil DPI
FDA issues new product specific guidances for diazepam nasal spray, epinephrine MDI, and tiotropium bromide SMI
The batch of new product specific guidances published by the FDA in November 2020 include guidances for generic OINDPs referencing Valtoco diazepam nasal spray, Primatene Mist epinephrine MDI, and Spiriva Respimat tiotropium bromide SMI. The agency approved Valtoco for the treatment of seizure clusters in January 2020. After a lengthy effort to reformulate … [Read more...] about FDA issues new product specific guidances for diazepam nasal spray, epinephrine MDI, and tiotropium bromide SMI