Drug firm Aurobindo Pharma has received tentative approval from the US health regulator USFDA for its generic Lacosamide tablets used in treatment of partial seizures in epilepsy patients.
Drug firm Aurobindo Pharma has received tentative approval from the US health regulator USFDA for its generic Lacosamide tablets used in treatment of partial seizures in epilepsy patients.
The US Food & Drug Administration (USFDA) has granted tentative approval to the company for its Abbreviated New Drug Application (ANDA) for Lacosamide tablets in the strengths of 50 mg, 100 mg, 150 mg and 200 mg, Aurobindo Pharma said in a statement on Thursday.
This ANDA is at present under litigation in the United States District Court for the District of Delaware, Aurobindo Pharma said.
The product is generic equivalent of USB Inc's Vimpat tablets and is used in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older, Aurobindo Pharma said.
Aurobindo Pharma including its arm Aurolife currently has a total of 193 ANDA approvals (165 final approvals and 28 tentative approvals) from USFDA, it added. Shares of Aurobindo Pharma on Thursday closed at Rs 1,225.95 per scrip on BSE, down 1.32 percent from its previous close.
Aurobindo Pharm stock price
On March 19, 2015, Aurobindo Pharma closed at Rs 1225.95, down Rs 16.4, or 1.32 percent. The 52-week high of the share was Rs 1279.05 and the 52-week low was Rs 504.50.
The company's trailing 12-month (TTM) EPS was at Rs 55.14 per share as per the quarter ended December 2014. The stock's price-to-earnings (P/E) ratio was 22.23. The latest book value of the company is Rs 137.42 per share. At current value, the price-to-book value of the company is 8.92.
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