Enforcement Report - Week of October 4, 2023
Tolmar's Generic Paliperidone Palmitate Receives Approval in the U.S.
NORTHBROOK, Ill., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Clarus Therapeutics Holdings, Inc. (Clarus) (OTC: CRXTQ), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen therapies, announced today that, subject to entry into definitive documentation, it and its wholly-owned subsidiary, Clarus Therapeutics, Inc., selected Tolmar, Inc., (Buffalo Grove, IL) as the winning bidder in a competitive bidding and auction proceeding for the sale of JATENZO (and certain related assets). The bidding and auction procedures were approved by the U. S. Bankruptcy Court for the District of Delaware [Docket No. 78] and the sale of JATENZO remains subject to final Bankruptcy Court approval on October 26, 2022.
Enforcement Report - Week of August 10, 2022
Enforcement Report - Week of December 22, 2021
BUFFALO GROVE, Ill., May 12, 2021 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a new product-specific billing code to identify FENSOLVI® (leuprolide acetate) for injectable suspension, indicated for the treatment of pediatric patients 2 years of age and older with Central Precocious Puberty (CPP). The new J-code is J1951 and becomes effective on July 1, 2021.
BUFFALO GROVE, Ill., Aug. 18, 2020 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today affirmed the full availability of FENSOLVI® (leuprolide acetate) for injectable suspension in its six-month dose (45mg) for pediatric patients with central precocious puberty (CPP). The company confirmed a complete inventory of product supply and also announced a production increase in response to reports of a shortage in the United States for a different leuprolide acetate injection product. Tolmar has a demonstrated record of providing consistent supply of its leuprolide acetate products in the U.S. and globally across approximately 89 countries, with no shortages to date.