Break from Blogging

I am taking a break for about 1 month from blogging.

I am sorry for this, please bear with me.

Thanks
Amit

Hospira Receives FDA Approval for 10 Gram Vial of Sterile Vancomycin Hydrochloride, USP

Hospira, Inc., the world leader in generic injectable pharmaceuticals, today announced it has received U.S. FDA approval for a 10 gram vial of Sterile Vancomycin Hydrochloride, USP, an anti-infective medication.

The details can be read here.

New Once-Daily RYZOLT (tramadol HCl extended-release tablets) Now Available in the U.S.

RYZOLT (tramadol HCl extended-release tablets) is now available from Purdue Pharma L.P. for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

The details can be read here.

Teva Announces Extension of Patent Protection for Azilect

May 6, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the USPTO has awarded a five year patent term extension to one of Teva's Orange Book patent (U.S. 5,453,446) covering Azilect (Rasagiline).

The details can be read here.

Lannett Company Receives FDA Approval for Pilocarpine HCI Tablets 7.5 mg Strength

May 8, 2009 - Lannett Company, Inc., a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. FDA of its supplemental Abbreviated New Drug Application for Pilocarpine HCI tablets, 7.5 mg, the generic equivalent of Salagen, marketed by Eisai Pharmaceuticals.

The details can be read here.

Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. FDA for its ANDAs for Mycophenolate Mofetil Tablets, 500 mg, and Mycophenolate Mofetil Capsules, 250 mg.

Jubilant Organosys gets US FDA approval for Draximage Sestamibi

Jubilant Organosys's US based subsidiary Draximage LLC has received US FDA approval for its ANDA for Draximage's generic Sestamibi. The product is found to be bioequivalent and therapeutically equivalent to reference listed drug Cardiolite.

The details can be read here.

Ranbaxy starts phase-III trials for its new anti-malarial molecule

Ranbaxy Laboratories Limited started phase-III clinical trials for its new anti-malaria combination drug, arterolane maleate + piperaquine phosphate in India, Bangladesh and Thailand.

the details can be read here.

Pfizer sues 3 Indian cos for patent infringement of its pain drug, Lyrica

Pfizer Inc has filed patent infringement suit against three Indian companies, namely Sun Pharma, Wockhardt Ltd and Lupin Ltd to block marketing generic equivalents to its blockbuster neuropathic pain management drug, Lyrica (pregabalin), in US.

The details can be read here.

AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product

May 4 -- AstraZeneca today announced the submission of a new drug application to the U.S. FDA seeking approval for a product combining low dose aspirin with esomeprazole magnesium for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers in patients at risk.

The details can be read here.

Ranbaxy Voluntarily Recalls Nitrofurantoin Capsules in the U.S.

Ranbaxy Pharmaceuticals Inc. (RPI) announced today that it is conducting a voluntary recall of all lots of Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, USP 100 mg currently on the market in the U.S.

The details can be read here.

Warner Chilcott Files New Lawsuit for Infringement of DORYX Patent

Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd. have filed a second lawsuit against Mylan Pharmaceuticals Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 which covers DORYX, a tetracycline-class oral antibiotic.

The details can be read here.

Patent Office rejects Gilead's application for crystalline form of HBV drug

The Indian Patent Office has rejected patent protection for Gilead Sciences Inc's crystalline form of adefovir dipivoxil, a new form of its Hepatitis B drug Hepsera, in a pre-grant opposition filed by Ranbaxy Laboratories

The details can be read here.

CSL Behring Submits BLA Requesting Approval of Subcutaneous Human Immunoglobulin for Use as Replacement Therapy in Patients with Primary Immunodeficie

May 1, 2009 - CSL Behring announced today it has submitted a biologics license application (BLA) to the USFDA requesting approval to market its 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (IgSc), in the United States for weekly replacement therapy in patients with primary immunodeficiencies.

The details can be read here.

Creon (Pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines

May 1, 2009 – Solvay Pharmaceuticals, Inc. today announced that the U.S. FDA approved CREON (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. CREON is the first and only pancreatic enzyme product (PEP) to receive FDA approval under new guidelines for the class.

The details can be read here.

FDA Approves Dysport for Therapeutic and Aesthetic Uses

April 30, 2009— Medicis and Ipsen today announced the U.S. FDA approval of the Biologics License Application (BLA) for DYSPORTTM (abobotulinumtoxinA), an acetylcholine release inhibitor and a neuromuscular blocking agent.

The details can be read here.

Basilea's Toctino Receives Marketing Authorization in Netherlands

Basilea Pharmaceutica Ltd. announces that Toctino (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids, has been approved by the Dutch Medicines Evaluation Board.

The details can be read here.

Fincor Makes a Share Transfer and Enters the Market With ACTRx a New Malaria and Dengue Fever Treatment

Fincor, acquired a majority of ACTRx International Inc., which combines several natural drugs to fight Malaria and Dengue fever and looks to become a premier global supplier of Malaria and Dengue cures, preventatives, maintenance and information products and services.

The details can be read here.

Orion Corporation (FI) - Orion and Wockhardt settle patent dispute

April 29, 2009--Orion Corporation and Wockhardt USA, LLC and Wockhardt Limited today announce that they have executed a settlement agreement on lawsuits filed by Orion in the United States against Wockhardt regarding Wockhardt's submission of abbreviated new drug applications for generic versions of Orion's Comtan and Stalevo products.

The details can be read here.