Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based KV Pharmaceutical Company has received final approval from the FDA to market its 100mg and 200mg strengths of metoprolol succinate extended-release tablets for the treatment of hypertension.
Subscribe to our email newsletter
The extended-release tablets are a generic version of UK pharmaceutical company AstraZeneca’s Toprol-XL treatment.
KV said that as it was the first to file the application with the FDA, the company expects to be granted a 180-day generic exclusivity period for marketing the two doses. The company hopes to be shipping the treatments in the near future.
KV added that pending receipt of FDA approval of its application to market the 25mg and 50mg doses of the extended release tablets, the company will eventually be able to offer all four dosage strengths of generic metoprolol succinate.
Marc Hermelin, vice chairman and CEO of KV, said: “Today marks the most significant generic approval in the history of our Ethex Corporation generic/non-branded subsidiary.”
KV’s filings to market the metoprolol succinate extended-release tablets were the subject of patent infringement litigation filed by AstraZeneca against the company and two co-defendants. Both patents have since been held invalid. The decision on AstraZeneca’s appeal of this ruling is pending, KV said.