Hikma launches generic Advair Diskus® following FDA approval
WEBLondon, 17 December 2020 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces it has received FDA approval for and launched its generic version of GlaxoSmithKline’s Advair Diskus® [1] (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
Albuterol Sulfate (Hikma Pharmaceuticals USA Inc.): FDA …
WEBJan 1, 2023 · Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
DailyMed - ALBUTEROL SULFATE aerosol, metered
WEBJan 1, 2023 · Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for ... CONTRAINDICATIONS. Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any ...
Fluticasone Propionate and Salmeterol Inhalation Powder
WEBHikma Pharmaceuticals USA Inc. generic Fluticasone Propionate and Salmeterol Inhaler, USP contains a combination of fluticasone propionate (100 or 250 mcg) and salmeterol (50 mcg) as a powder formulation for oral inhalation.
FDA Approves First Generic of a Commonly Used Albuterol Inhaler …
WEBThe U.S. Food and Drug Administration today approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of...
Hikma, Vectura team up to target GSK respiratory drugs
WEBNov 8, 2018 · Hikma says interactions with the FDA have led the companies to believe that Vectura’s Open-Inhale-Close dry powder inhaler device can win the agency’s blessing as generic copies to GSK’s Ellipta products. Vectura will be responsible for developing the formulation for the products.
Vectura earns $11m milestone as Hikma receives US FDA …
WEBDec 17, 2020 · Vectura Group plc (LSE: VEC) (“Vectura”), an industry-leading specialist inhalation CDMO, today announces that its partner Hikma Pharmaceuticals has launched its generic version of GlaxoSmithKline’s Advair Diskus®1 (fluticasone propionate and salmeterol inhalation powder), 100mcg/50mcg and 250mcg/50mcg doses, in the US.
Vectura, Hikma team up to develop generic versions of GSK’s …
WEBNov 9, 2018 · UK-based drug manufacturers Vectura Group and Hikma Pharmaceuticals have collaborated to develop and commercialise a generic version of GSK’s Ellipta inhaler products indicated for respiratory conditions.
Hikma Pharma Receives CRL From FDA For Generic Advair …
WEBSep 22, 2020 · (RTTNews) - Hikma Pharmaceuticals Plc (HIK, HIK.L) said it received a minor complete response letter or CRL from the US Food and Drug Administration or FDA in relation to its abbreviated new...
Vectura highlights update made by Hikma on launch of generic …
WEBApr 21, 2021 · Hikma will immediately resume launch activities of its generic product for Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.” Click here for the full update.