The FDA approved Merck’s Emend (aprepitant) for use with other antiemetic medicines for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy.
The FDA has approved Warner Chilcott and LEO Pharma’s NDA for Taclonex. Taclonex is a topical ointment containing a combination of calcipotriene and betamethasone dipropionate for the treatment of psoriasis vulgaris in adults.
AstraZeneca lost a key patent case over its beta-blocker Toprol XL (metoprolol succinate), exposing the product to generic competition. The UK-based drug maker said it would appeal the judgment by the US District Court for the Eastern District of Missouri in favor of KV Pharmaceutical, Andrx and Novartis unit Eon Labs. In its decision, the court found that the patents asserted by AstraZeneca—the compound patent and the composition patent that cover Toprol XL—were invalid. Both patents were previously set to expire on Sept. 17, 2007.
A federal court in Chicago has upheld the patent on Pfizer’s calcium channel blocker Norvasc (amlodipine besylate), warding off generic drug maker Apotex from selling a cheaper, generic version of the drug until September 2007. The judge in the case ruled that the patent covering amlodipine besylate was valid, enforceable and infringed by the Canadian drug maker’s product. Pfizer said US Norvasc patents continue to face legal challenges from other generic drug makers.
Pfizer will pay Sanofi-Aventis $1.3 billion to acquire worldwide rights to the inhaled human insulin Exubera, a product both companies previously planned to co-develop, co-promote and co-manufacture. The FDA is expected to decide within the next few weeks whether Pfizer can begin selling Exubera.
The FDA announced the approval of updated labeling for two topical eczema drugs, Novartis’ Elidel Cream (pimecrolimus) and Astellas Pharma’s Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that patients using these prescription medicines are aware of this concern. The new labeling also clarifies that these drugs are recommended for use as second-line treatments. This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended.