Soma Pharmacy Blognews

Venus Remedies Launches Infusion FDC Antibiotic, Mebatic Venus Remedies has launched Mebatic, an antibiotic combination in infusion form, to cure severe gastro intestinal (GI) infections. Mebatic contains a combination of floroquinolone and nitroimidazole.

Lannett Company plans to submit its NDA for Morphine Sulfate products to FDA Lannett Company, Inc. today announced plans to submit its New Drug Application (NDA) for its Morphine Sulfate products to the U.S. Food and Drug Administration (FDA) at the end of the month.

Hovione announces filing of new drug application in Japan for the influenza drug CS-8958 Hovione is announcing the filing of a new drug application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione’s TwinCaps(R) inhaler.

FDA accepts Teva Pharmaceutical Industries’ BLA for XM02 G-CSF Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva’s Biologics License Application (BLA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in [...]

Javelin Pharmaceuticals’ NDA for Dyloject Injection accepted for formal review Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for pain management, today announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, [...]

FDA approves INNOPHARMA’s ibutilide fumarate injection ANDA INNOPHARMA LLC announced today FDA approval of the Abbreviated New Drug Application (ANDA) for ibutilide fumarate injection (the generic equivalent of Corvert® from Pfizer Inc).

Xiaflex receives FDA approval for treatment of Dupuytren’s contracture The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren’s contracture, which can affect a person’s ability to straighten and properly use their fingers.

FDA approves Taro Pharmaceutical Industries’ levetiracetam tablets ANDA Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg (“levetiracetam tablets”).

Cytheris broadens patent protection for recombinant human interleukin-7 Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application “Glycosylated IL-7, Preparation and Uses”, US Patent [...]

Spectrum Pharmaceuticals signs co-development and commercialization agreement with TopoTarget A/S Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has entered into a co-development and commercialization agreement with TopoTarget A/S for Belinostat, a novel histone deacetylase (HDAC) inhibitor.