Pharma firm Strides Arcolab today said its subsidiary Onco Therapies Ltd has received final approval from the US health regulator for its generic version of Oxaliplatin injection used for treating cancer.
The nod from the US Food and Drug Administration is for Oxaliplatin injection in strengths of 50mg/10ml and 100mg/20ml, the company said in a statement.
"The company had in November 2011 received tentative approval from USFDA based on a Para III filing. This approval was later converted to a Para IV filing based on which USFDA has now granted final approval," it added.
A company usually makes a Para III filing when it does not have any plans to sell the generic drug until the expiry of the original patent, whereas a Para IV filing is made when it believes that its generic product does not infringe innovator's patent.
Citing IMS data, Strides said the US market for generic Oxaliplatin is approximately USD 1.5 billion.
"Oxaliplatin is part of the oncology portfolio licensed to Pfizer for the US market and the product is available for immediate launch," the company added.
Oxaliplatin is a chemotherapy drug used to treat advanced cancer of the colon and rectum. It is used in combination with other medications to slow or stop cancer cell growth.
Strides' scrip was trading at Rs 757.85 on the BSE in the afternoon, up 4.62% from previous close.
Strides Arcolab stock price
On November 27, 2015, at 12:00 hrs Strides Arcolab was quoting at Rs 1361.00, down Rs 6.75, or 0.49 percent. The 52-week high of the share was Rs 1412.45 and the 52-week low was Rs 739.25.
The company's trailing 12-month (TTM) EPS was at Rs 27.83 per share as per the quarter ended September 2015. The stock's price-to-earnings (P/E) ratio was 48.9. The latest book value of the company is Rs 185.44 per share. At current value, the price-to-book value of the company is 7.34.
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