BERLIN, Conn., March 8, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Asenapine Sublingual Tablets in 5mg strength (generic for Saphris®). Breckenridge plans to launch this strength immediately. Breckenridge previously launched the product's 2.5mg and 10mg strengths and will now market all three strengths. This product was developed in collaboration with MSN Laboratories Private Limited. According to industry sales data, Saphris® generated annual sales of $233 million during the twelve months ending December 2020.
Results from Pivotal, Phase 3 Trial for SECUADO® (asenapine) Published in Journal of Clinical Psychiatry
MIAMI & JERSEY CITY, N.J.--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that SECUADO® (asenapine) transdermal system, the first-and-only transdermal patch formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with schizophrenia, is now available by prescription in the U.S.1
Alembic Pharma Generic Asenapine Receives Tentative Approval in US
Noven Pharmaceuticals won approval from the U.S. Food and Drug Administration (FDA) for its transdermal schizophrenia patch.
Sigmapharm Labs LLC Generic Asenapine Maleate Receives Tentative Approval In The US
MIAMI & JERSEY CITY, N.J.--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Ltd., announced today that secondary endpoint data from the pivotal Phase III study for HP-3070 (asenapine) transdermal drug delivery system (TDDS), an investigational product for the treatment of schizophrenia, will be featured as a poster presentation at the American Psychiatric Association (APA) 172nd Annual Meeting in San Francisco, May 18 – 22, 2019.
MIAMI & JERSEY CITY, N.J.--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Ltd., announced today that the primary and key secondary efficacy endpoints and safety results from the pivotal Phase III study for HP-3070 (asenapine) transdermal drug delivery system (TDDS), an investigational product for the treatment of schizophrenia, will be featured as an oral presentation at the 74th Society of Biological Psychiatry (SOBP) Annual Meeting in Chicago, May 16 – 18, 2019.
Sigmapharm Labs Llc Asenapine Maleate Receives Approval In The US
FDA Confirms Paragraph IV Patent Challenge of Saphris (Asenapine Maleate) Sublingual Tablets