Searle Calan SR/Knoll Isoptin SR
Searle submits preliminary data to FDA from a study completed in September on the steady-state pharmacokinetics and pharmacodynamics of sustained-release verapamil. In Oct. 3 comments on Knoll's recommendations to FDA for verapamil SR bioequivalence studies, Searle said it will soon submit final results of the study to FDA. Searle is seeking a delay in the approval of ANDA suitability petitions for the sustained-release formulation until FDA has reviewed the results of the study. Exclusivity for sustained-release verapamil runs out on Dec. 16. At least two companies have submitted ANDA suitability petitions for verapamil SR -- Lederle, in July, for a 120 mg dosage form and Pioneer Pharmaceuticals, in September, for 120 mg and 180 mg dosage strengths.
You may also be interested in...
Sandoz Canada has become the first manufacturer to launch generic versions of posaconazole and silodosin in Canada. The company launched the generic version of Allergan’s Rapaflo (silodosin) after a Canadian court ruled that Sandoz did not infringe a key formulation patent.
US healthcare insurance provider Health Net failed to respect Amarin’s patent rights in the way it distributed Hikma’s generic version of Vascepa (icosapent ethyl), the originator contends in an expanded induced infringement suit.
Netherlands' Authority for Consumers and Markets has reprimanded a dietary supplements player for purchasing fake followers and likes on social media to exaggerate the popularity of its products. It is the first case of its kind in the country.