HAUPPAUGE, N.Y.--(BUSINESS WIRE)--Feb 8, 2010 - Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. [more]
PITTSBURGH, Feb. 4 /PRNewswire-FirstCall/ -- Mylan Inc. (NASDAQ:MYL) today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg. This product is the generic version of Caduet® Tablets, which combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium. [more]
TORONTO, Feb. 3 /CNW/ - An extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R)(1), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics.( [more]
MONMOUTH JUNCTION, N.J., Feb. 2 /PRNewswire/ -- 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). [more]
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Feb 2, 2010 - Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg (“levetiracetam tablets”). [more]
Newtown St. Boswells, Scottish Borders, 1st February 2010 -- Syntropharma, an emerging pharmaceutical company focussed on niche therapeutics and transdermal products, has signed an agreement with Ranbaxy Pharmaceuticals Inc. (“RPI”), a wholly owned subsidiary of Ranbaxy Laboratories Limited (“RLL”), for the marketing and distribution of one of its development projects in the United States. In addition to marketing and distribution, RPI, a recognized and established leader in the US generic pharmaceutical industry, will assume responsibility for regulatory affairs in the collaboration and will pursue approval of the product dossier with the FDA. [more]
PITTSBURGH, Jan. 29 /PRNewswire-FirstCall/ -- Mylan Inc. (NASDAQ:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP, the generic version of Braintree Laboratories' GoLytely laxative. [more]
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan 28, 2010 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread® (tenofovir disoproxil fumarate). [more]
Jerusalem, Israel, January 26, 2010 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Schering-Plough's brain tumor treatment Temodar (temozolomide). The Court found that U.S. Patent No. 5,260,291 is not enforceable due to prosecution laches and inequitable conduct. [more]
WHITEHOUSE STATION, N.J., Jan. 26, 2010 – Merck & Co., Inc. announced today that the U.S. District Court for the District of Delaware ruled against the company in a patent infringement suit against Teva Pharmaceuticals USA Inc. [more]
NEW YORK, Jan. 25 /PRNewswire-Asia-FirstCall/ -- NeoStem, Inc. ("NeoStem" or the "Company") (NYSE Amex: NBS), an international biopharmaceutical company with operations in the U.S. and China, announced that it recently was advised that its Suzhou Erye Pharmaceutical subsidiary ("Erye") received approval as of November 6, 2009 from the State Food and Drug Administration (SFDA) in China to manufacture and sell omeprazole 20mg capsules. [more]
BALTIMORE, January 21, 2010 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Memantine Hydrochloride tablets, 5mg and 10mg. [more]
JERUSALEM--(BUSINESS WIRE)--Jan 21, 2010 - Teva Pharmaceutical Industries Ltd. announced today that the FDA has granted tentative approval for the ompany's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' breast cancer treatment Femara (letrozole) Tablets, 2.5 mg. Final approval of Teva's Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011. [more]
MORRISTOWN, N.J., Jan. 19 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE:WPI) , a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lidocaine topical patch 5% prior to the expiration of U.S. Patent No. 5,827,529. Watson's lidocaine topical patch 5% is a generic version of Endo's Lidoderm. [more]
CHADDS FORD, Pa., Jan. 19 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (NASDAQ:ENDP) announced today that its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. have received a Paragraph IV Certification Notice from Watson Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of LIDODERM® (lidocaine topical patch 5%). [more]
HAYWARD, Calif.--(BUSINESS WIRE)--Jan 15, 2010 - Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its Welchol (Colesevelam HCl) tablets, 625 mg. [more]
WASHINGTON, Jan. 13 /PRNewswire-USNewswire/ -- Federal Trade Commission Chairman Jon Leibowitz and key members of Congress, including Representative Chris Van Hollen, Chairman Bobby Rush, and Representative Mary Jo Kilroy, today renewed their call for legislation that would put an end to anticompetitive patent settlements, which drug manufacturers have been using to keep less-expensive medicines off the market and charge consumers billions of dollars a year in higher drug prices. [more]
VALLEY FORGE, Pa.--(BUSINESS WIRE)--Jan 11, 2010 - AmerisourceBergen (NYSE:ABC), under its' PRxO® Generics Solution, today announced a new program for long term care pharmacies and an expanded program for retail pharmacies. The new solutions are tailored to better meet customer needs as generic prescription demands continue to increase. [more]
PITTSBURGH, Jan. 11 /PRNewswire-FirstCall/ -- Mylan Inc. (NASDAQ:MYL) today confirmed that it was sued by Cephalon Inc. and Cephalon France in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Armodafinil Tablets, 50 mg, 150 mg and 250 mg. Armodafinil Tablets are the generic version of Nuvigil® Tablets, which are used to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypnea syndrome, narcolepsy and shift work sleep disorder. [more]
WASHINGTON, Jan. 11, 2010--From 2000 to 2008, 416 brand-name drug products—different drug strengths and dosage forms of the same drug brands—had extraordinary price increases. These 416 brand-name drug products represented 321 different drug brands. [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.
