Drug maker Aurobindo Pharma Ltd today said it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Rizatriptan Benzoate Tablets used in the treatment of migraine.
The product which was tentatively approved by the FDA earlier, is ready for launch, a statement from Aurobindo said.
Rizatriptan Benzoate Tablets 5mg (base) and 10mg (base) is the generic equivalent of Merck and Co's Maxalt Tablets of equivalent dose and is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.
The annual sale of the product is approximately USD 300 million for 12 months ending March 2012 according to IMS data, the release said.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad.
Aurobindo scrip is traded at Rs 193.25 apiece on BSE in the afternoon trade.
Aurobindo Pharm stock price
On November 30, 2015, Aurobindo Pharma closed at Rs 810.65, down Rs 7.65, or 0.93 percent. The 52-week high of the share was Rs 1540.55 and the 52-week low was Rs 490.50.
The company's trailing 12-month (TTM) EPS was at Rs 25.30 per share as per the quarter ended September 2015. The stock's price-to-earnings (P/E) ratio was 32.04. The latest book value of the company is Rs 94.68 per share. At current value, the price-to-book value of the company is 8.56.
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