Pharmaceutical manufacturer Zydus Cadila said that it received tentative approval from the US Food and Drug Administration for sales of a generic equivalent of UCB Inc’s Vimpat tablets.
A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug.
Lacosamide is an anticonvulsant or antiepileptic drug, used to prevent and control seizures. It works by reducing the spread of seizure activity in the brain.
The drug will be sold in doses of 50 mg, 100 mg, 150 mg and 200mg and manufactured at Zydus’ facility in Moraiya, Ahmedabad.
With the latest approval, the group has so far received 261 approvals and filed over 350 applications for the sales of its generic drugs.
Headquartered in Ahmedabad, Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and even in the United States and Brazil.