Upsher-Smith Laboratories, Inc. announced the initiation of a Phase III clinical trial to evaluate the safety and efficacy of USL261, an investigational intranasal midazolam, for the rescue treatment of seizures in patients on stable anti-epileptic drug (AED) regimens who require control of...
Columbia Laboratories, Inc. (Nasdaq: CBRX) and Watson Pharmaceuticals, Inc. (NYSE: WPI) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women...
Impax Laboratories, Inc. (NASDAQ:IPXL) today confirms that Pfizer Inc., Pharmacia & Upjohn Company LLC and Pfizer Health AB (collectively, "Pfizer") have filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey in connection with Detrol®...
RockHard Laboratories has announced that it is conducting a voluntary nationwide recall of the company's dietary supplements sold under the brand names RockHard Weekend and Pandora specific to the following Lot Numbers: RockHard Weekend Lot Numbers: 100159 and 100260 sold as blister packs, 3ct...
UK based Trimega Laboratories is pleased to announce that it has been recognized as having met the standards set by the prestigious Investors in People (IIP) Standard. Its accreditation follows an examination by the Employer Representative Quality Board of IIP and reflects the commitment and...
Brand-Nu Laboratories, a leading US-based high purity chemical manufacturer and distributor, has introduced Chlophedianol Hydrochloride, also known as Clofedanol Hydrochloride JP, to its product portfolio of active pharmaceutical ingredients (APIs). Chlophedianol Hydrochloride has been...
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of Opana® ER (oxymorphone hydrochloride) 5, 7.5, 10, 15, 20, 30 and 40 mg tablets...
Impax Laboratories, Inc. (NASDAQ:IPXL) confirms that it has initiated a challenge of a patent listed by Shionogi Pharma, Inc. in connection with its Fenoglide® (fenofibrate) tablets, 40 and 120 mg. Impax filed its Abbreviated New Drug Application (ANDA) for a generic version of Fenoglide® with...
Impax Laboratories, Inc. (NASDAQ:IPXL) confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) tablets, 625 mg. Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a...
Impax Laboratories, Inc. (NASDAQ:IPXL) confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) tablets, 625 mg. Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a...
Impax Laboratories, Inc. (NASDAQ:IPXL) confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) tablets, 625 mg. Impax filed its Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a...