BURLINGTON, Mass., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced that the American Academy of Orthopaedic Surgeons (AAOS) included ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in its updated evidence-based clinical practice guidelines for the management of osteoarthritis (OA) of the knee.1
TORONTO and CHICAGO and MONTREAL, June 09, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) announced today that it is initiating immediate availability of Triamcinolone Hexacetonide Injectable Suspension, USP (20 mg/ml) (TH) in the United States via the U.S. Food and Drug Administration’s (FDA) CDER Drug Shortage program. More information about the FDA’s Drug Shortage program is available at: FDA Drug Shortages.
MONTREAL, July 09, 2020 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) is pleased to announce that Triamcinolone Hexacetonide Injectable Suspension 20 mg/mL (TH) has been approved for inclusion on the Alberta Drug Benefit List (ADBL), the Saskatchewan Drug Plan, the Newfoundland and Labrador Prescription Drug Program (NLPDP) and the Yukon Drug Formulary for the treatment of Juvenile Idiopathic Arthritis (JIA). TH has also been approved for inclusion on the Ontario Drug Benefit Formulary/Comparative Drug Index (ODB Formulary/CDI) and the Non-Insured Health Benefits – Drug Benefit List for its full Health Canada-approved indication which includes approved use in both adults and adolescents. TH is the longest acting corticosteroid for intra-articular injection, often lasting twice as long as comparator products.
The FDA on Wednesday said it is requiring a boxed warning and medication guide for Merck’s asthma and allergy drug Singulair (montelukast) and its generics to strengthen existing warnings about the risk of neuropsychiatric events, including suicides, linked to the drug.
The US Food and Drug Administration (FDA) on Wednesday said it is requiring a boxed warning and medication guide for Merck’s asthma and allergy drug Singulair (montelukast) and its generics to strengthen existing warnings about the risk of neuropsychiatric events, including suicides, linked to the drug.
Flexion Therapeutics Announces FDA Approval of sNDA to Revise ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) Product Label
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the first three patients were enrolled in a clinical trial to evaluate the efficacy of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in patients with either shoulder osteoarthritis (OA) or adhesive capsulitis (AC), also known as frozen shoulder. The Phase 2 double-blind, placebo-controlled, study is expected to enroll up to 250 patients – approximately 135 with shoulder OA and 115 with shoulder AC.
Roche hopes its new drug Xofluza can pick up flu sales lost to Tamiflu generics. But it might end up competing with over-the-counter Tamiflu, too. Sanofi has snapped up Tamiflu's over-the-counter rights in the U.S., aiming to take the flu fighter to consumers without a prescription.
Imprimis NJOF, LLC Receives FDA Warning Letter
Shares in Georgia small-cap Clearside Biomedical are in free fall this morning after the biotech revealed its top pipeline drug failed a phase 3 trial in retinal vein occlusion, a common cause of vision loss.