Mylan confirms generic Lescol patent challenge
Taking calcium and vitamin D supplements does not reduce breast cancer incidence in postmenopausal women, according to data from a randomized, doubled-blind, placebo-controlled trial published online November 11 in the Journal of the National Cancer Institute. Several observational and preclinical studies have suggested that vitamin D supplements may reduce breast cancer risk, but results have
Full Post: Taking calcium and vitamin D supplements does not reduce breast cancer risk
Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis’ Lescol(R) Capsules.
Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the product. The company filed an ANDA with the U.S. Food and Drug Administration (FDA) in June. Novartis filed a lawsuit Oct. 10 in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,354,772.
Fluvastatin Capsules, used in the treatment of high cholesterol, had approximately $60 million in sales for the twelve months ending June 30, 2008, according to IMS Health.
Currently, Mylan has 108 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities.
Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX Capsules. Mylan
Full Post: Mylan confirms first-to-file patent challenge of AMRIX capsules
Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg. Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Amrix with the U.S.
Full Post: Barr Labs confirms patent challenge of Amrix extended-release capsules
Mylan Inc. has 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 Fluoxetine Capsules USP, 10 mg and 20 mg. Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly’s
Full Post: Mylan Receives Final FDA Approval for the Generic Version of the Antidepressant Sarafem(R) Pulvules(R) Capsules
Mylan Inc. has announced that it and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis’ Femara. Mylan’s Vice Chairman and CEO Robert J. Coury commented: “We are very pleased to have reached this
Full Post: Mylan settles with Novartis on Femara
Mylan Inc. has announced that its subsidiary Dey L.P. has been issued several additional U.S. patents protecting the company’s Perforomist(R) Inhalation Solution, a chronic obstructive pulmonary disease (COPD) treatment. U.S. Patent No. 7,462,645 was issued Dec. 9, 2008, and is directed to treatment through the administration of a ready-to-use, storage stable composition of formoterol. This
Full Post: Dey L.P. issued new U.S. patents for Perforomist inhalation solution