Teva to appeal against Risedronate infringement decision
Teva Pharma 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 Procter & Gamble's Actonel® (Risedronate Sodium) Tablets, 5mg, 30mg and 35 mg. The Court found Procter & Gamble's US5,538,122 (Covers formulation) to be valid. Teva intends to appeal this decision.
Glenmark to hive off API, generic business
The Mumbai-based leading research oriented pharmaceutical company Glenmark is all set to start its new company- Glenmark Generics Ltd (GGL) from April 1, 2008. The company is transferring its domestic active pharmaceutical ingredients (APIs) business and generics formulations business to GGL. The new company is planning to enter in the capital market during first quarter of 2008-09. Glenmark is transferring its entire assets related to APIs and generic business, including brands, trademarks and employees, located at Goa, Ankleshwar, Kurkumbh and Mohol to GGL as a going concern. The new company will handle the development, manufacture and marketing of generic formulation and API businesses. Glenmark will continue to directly manage the novel R&D and branded formulation businesses of the Glenmark group including India, Brazil, Rest of Latin America (excluding Argentina), Russia/CIS, Africa and Asia.
Eisai's Rabeprazole gets US priority review
USFDA have granted priority (With in six months) review for a new application of Eisai Aciphex acid reflux drug, Japan's fourth-largest drug maker said.
Aciphex, known chemically as Rabeprazole sodium, belongs to a class of drugs known as proton pump inhibitors designed to suppress production of stomach acid that can burn and damage the esophagus, a condition known as gastroesophageal reflux disease.
Eisai announced that the USFDA had accepted a supplemental New Drug Application (NDA) for Aciphex for the short-term treatment of gastroesophageal reflux disease in patients of age 12-16.
It said the FDA has indicated it would grant the new application priority review status.Eisai derives nearly half of its U.S. drug sales from Aciphex and it is its second-biggest selling drug after Aricept, which is used to treat Alzheimer's disease.
Teva Pharma 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 Procter & Gamble's Actonel® (Risedronate Sodium) Tablets, 5mg, 30mg and 35 mg. The Court found Procter & Gamble's US5,538,122 (Covers formulation) to be valid. Teva intends to appeal this decision.
Glenmark to hive off API, generic business
The Mumbai-based leading research oriented pharmaceutical company Glenmark is all set to start its new company- Glenmark Generics Ltd (GGL) from April 1, 2008. The company is transferring its domestic active pharmaceutical ingredients (APIs) business and generics formulations business to GGL. The new company is planning to enter in the capital market during first quarter of 2008-09. Glenmark is transferring its entire assets related to APIs and generic business, including brands, trademarks and employees, located at Goa, Ankleshwar, Kurkumbh and Mohol to GGL as a going concern. The new company will handle the development, manufacture and marketing of generic formulation and API businesses. Glenmark will continue to directly manage the novel R&D and branded formulation businesses of the Glenmark group including India, Brazil, Rest of Latin America (excluding Argentina), Russia/CIS, Africa and Asia.
Eisai's Rabeprazole gets US priority review
USFDA have granted priority (With in six months) review for a new application of Eisai Aciphex acid reflux drug, Japan's fourth-largest drug maker said.
Aciphex, known chemically as Rabeprazole sodium, belongs to a class of drugs known as proton pump inhibitors designed to suppress production of stomach acid that can burn and damage the esophagus, a condition known as gastroesophageal reflux disease.
Eisai announced that the USFDA had accepted a supplemental New Drug Application (NDA) for Aciphex for the short-term treatment of gastroesophageal reflux disease in patients of age 12-16.
It said the FDA has indicated it would grant the new application priority review status.Eisai derives nearly half of its U.S. drug sales from Aciphex and it is its second-biggest selling drug after Aricept, which is used to treat Alzheimer's disease.
