Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that a new patent has been issued by the U.S. Patent and Trademark Office (USPTO) relating to its tamper-resistant DETERx™ formulation platform. US Patent Number 7,771,707 contains claims that cover Collegium’s proprietary extended-release formulations, which are designed to resist dose dumping when subjected to a variety of physical methods of tampering. Continue Reading
Perrigo Company announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for butoconazole nitrate vaginal cream, 2% and that is has notified KV Pharmaceutical Company, the owner of the New Drug Application as well as FemmePharma, the listed owner of the patent, of its ANDA filing. KV is a licensee under the patent. Perrigo believes it is first-to-file on this product. Continue Reading
A new film on depression, drugs and alternative paths to better mental health will premiere Wednesday, May 12th at UltraStar Cinemas in Del Mar, CA. An answer to the pharmaceutical industry’s media blitz, Living Life Films’ “Changing Our Minds” questions society’s values while revealing interesting and disturbing truths about psychiatry and the drug industry. Continue Reading
Impax Laboratories, Inc. today confirms that it has initiated a challenge of the patent listed by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with its TRILIPIX® (choline fenofibrate) delayed-release capsules, 135 mg and 45 mg. Continue Reading
Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration has provided guidance on the clinical program required to assess the approvability of Restanza™ (cethromycin), a novel oral once-a-day antibiotic, in the treatment of outpatient community acquired bacterial pneumonia (CABP) as well as biodefense indications including anthrax, plague and tularemia. Continue Reading
Dainippon Sumitomo Pharma America, Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd., today announced that the U.S. Food and Drug Administration recently accepted for review the lurasidone New Drug Application (NDA) for the treatment of patients with acute schizophrenia. The NDA was submitted to FDA on December 30, 2009 and will receive a standard review. Continue Reading
InterMune, Inc. announced today that the U.S. Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of Esbriet® (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. Continue Reading
Taro Pharmaceutical Industries Ltd. today reported that it received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Fluorouracil Topical Cream USP, 5%. Continue Reading
ISTA Pharmaceuticals, Inc., today announced the Company’s supplemental New Drug Application (sNDA) for once-daily XiDay™ (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). Continue Reading
Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma Immunology (AAAAI) annual meeting. Continue Reading
