BALTIMORE, Feb. 8 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipments of the product have already commenced. [more]
SCHAUMBURG, Ill., Feb. 8 /PRNewswire/ -- Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has received FDA approval of labetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension. The product will be available in two vial sizes - 100 mg per 20 mL and 200 mg per 40 mL, multi-dose vials. According to the American Heart Association, more than 70 million Americans have hypertension, or high blood pressure. IMS estimates that 2009 sales of labetalol HCl injection in the United States approximated $9 million. Sagent expects to launch the product shortly. [more]
Barcelona, February, 8th 2010.- Almirall informs that the European Commission has granted a marketing authorisation for silodosin. The product will be marketed in Spain by Almirall and Recordati under the trademarks Silodyx and Urorec, respectively, 4 mg and 8 mg in hard capsules for the treatment of benign prostatic hyperplasia (BPH). [more]
MALVERN, Pa., Feb. 3 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. , a specialty biopharmaceutical company, just announced that it has received marketing approval from the U.S. Food and Drug Administration for Xiaflex (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. [more]
LAVAL, QC and PRINCETON, NJ, February 03, 2010 /PRNewswire-FirstCall/ - Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Oleptro (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. [more]
SILVER SPRING, Md., Feb. 2 /PRNewswire-USNewswire/ -- 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. [more]
LYNBROOK, N.Y., Feb. 2 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (NASDAQ:BSTC) , a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX(TM), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. Dupuytren's contracture is a debilitating disease resulting from excessive collagen deposition that causes contractures of the fingers. The Company's partner, Auxilium Pharmaceuticals Inc., expects to launch XIAFLEX in late March, 2010. [more]
IRVINE, Calif.--(BUSINESS WIRE)--Allergan, Inc. today announced the U.S. Food and Drug Administration’s approval of Juvederm XC, a new formulation of the currently FDA-approved Juvederm dermal filler and the latest advancement in hyaluronic acid (HA) dermal fillers. [more]
PHILADELPHIA, Jan. 29 /PRNewswire/ -- GlaxoSmithKline announced today that the FDA has granted accelerated approval for a new combination regimen using Tykerb (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer. [more]
SILVER SPRING, Md., Jan. 29 /PRNewswire-USNewswire/ -- The FDA today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated. [more]
RESEARCH TRIANGLE PARK, N.C., Jan. 29 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Lamictal XR (lamotrigine) Extended-Release Tablets as once-a-day, add-on therapy for epilepsy in patients ages 13 years and older with primary generalized tonic-clonic seizures. [more]
NES-ZIONA, Israel, Jan. 29 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc., (OTC:PBTH) (BULLETIN BOARD: PBTH) today noted the European Commission (EC) approval of Merck & Co., Inc.'s ELONVA, a long-acting CTP-modified version of the fertility drug follicle stimulating hormone (FSH). With the EC approval, Merck has marketing authorization for ELONVA with unified labeling valid in all European Union Member States. [more]
BALTIMORE, Jan. 28 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its Perindopril Erbumine tablets, 2mg, 4mg and 8mg. Commercial shipments of the product will commence shortly.
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WHITEHOUSE STATION, N.J., Jan. 28 /PRNewswire-FirstCall/ -- Merck & Co., Inc., which operates outside the U.S. and Canada as MSD, today announced the European Commission (EC) approval of Elonva (corifollitropin alfa injection). Elonva is indicated for controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. [more]
BRIDGEWATER, N.J., Jan. 27 /PRNewswire/ -- Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Prezista (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies. Both ARTEMIS and TITAN evaluated the efficacy and safety of Prezista with ritonavir vs. lopinavir/r in combination with other antiretrovirals (ARVs) for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients, respectively. [more]
SILVER SPRING, Md., Jan. 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL. [more]
COLUMBUS, Ohio, Jan. 26 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Administration. This product is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. [more]
DORVAL, QC, Jan. 26 /CNW/ - Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST. [more]
PRINCETON, N.J., Jan. 26 /PRNewswire/ -- Novo Nordisk (NVO) announced that the U.S. Food and Drug Administration (FDA) approved the new drug application for Victoza (liraglutide [rDNA origin] injection), the first once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. [more]
PARIS--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that on 20 January 2010, the European Commission approved Orencia (abatacept) in combination with methotrexate for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients six years of age and older who have had an insufficient response to other DMARDS, including at least one TNF inhibitor. [more]
Mergers & Acquisitions, Partnerships, & Collaborations 2010 – Review and Outlook
This PharmaLive Special Report analyzes the healthcare industry’s M&As of 2009, providing a comprehensive listing of companies’ M&A activity and detailing the top 20 deals within each of the Pharmaceutical, Biotechnology, Specialty, and Medical Device sectors, and previews potential M&A activity within the healthcare arena for 2010.
The introductory rate of $395 expires February 17, 2010.
