The FDA hit Nabriva Therapeutics' antibiotic Contepo with a second complete response letter based on issues with a European contract manufacturer.
DUBLIN, Ireland, June 19, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) resubmission seeking marketing approval of CONTEPO (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.
EMA has recommended that fosfomycin medicines given by infusion (drip) into a vein should only be used to treat serious infections when other antibiotic treatments are not suitable. Fosfomycin medicines given by mouth can continue to be used to treat uncomplicated bladder infections in women and adolescent girls. They can also be used to prevent infection in men who undergo a procedure whereby a tissue sample is taken from their prostate (biopsy).
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DUBLIN, Ireland, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPO™ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs).
DUBLIN, Ireland, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPOâ„¢ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs).
DUBLIN, Ireland, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its New Drug Application (NDA) resubmission for marketing approval of CONTEPOâ„¢ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs).
Nabriva Therapeutics plc (NASDAQ: NBRV), a commercial-stage biopharmaceutical company engaged in the development of innovative anti-infective agents to treat serious infections, announced today that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for CONTEPOâ„¢ (fosfomycin) for injection for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis. Nabriva anticipates a six-month review period by the FDA.
Two orphan medicines1 received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.
Nabriva, which is based in Dublin, Ireland and has US headquarters in King of Prussia, Pennsylvania, will make the upfront payment of $8.2M in ordinary shares to Zavante’s former shareholders, based in San Diego, California. The intravenous antibiotic drug Contepo (fosfomycin) is Zavante’s novel treatment, potentially first in class in the US as a therapy for serious infections caused by multi-drug-resistant Gram-negative and Gram-positive bacteria.