Ranbaxy loses 6 mths exclusivity for generic antiviral drug

Written By Unknown on Kamis, 06 November 2014 | 23.26

FDA has rescinded the previously granted tentative approvals for Ranbaxy's ANDAs for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride tablets USP, 450 mg, Ranbaxy Laboratories said.

Drug firm  Ranbaxy Laboratories today said the US health regulator has revoked its tentative approvals for its generic anti-viral drug and stomach and esophagus problems treatment tablets.

"As a consequence, in FDA's view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets USP, 450 mg," Ranbaxy Laboratories said in a filing to BSE.

The communication from US Food and Drug Administration (USFDA) said that Ranbaxy's ANDAs of concern did not have any data integrity issues. However it added that "its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted."

FDA has rescinded the previously granted tentative approvals for Ranbaxy's ANDAs for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg and for valganciclovir hydrochloride tablets USP, 450 mg, Ranbaxy Laboratories said.

"Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights," the company said.

Ranbaxy Labs stock price

On November 05, 2014, Ranbaxy Laboratories closed at Rs 654.15, up Rs 13.00, or 2.03 percent. The 52-week high of the share was Rs 667.30 and the 52-week low was Rs 306.05.


The company's trailing 12-month (TTM) EPS was at Rs 20.93 per share as per the quarter ended September 2014. The stock's price-to-earnings (P/E) ratio was 31.25. The latest book value of the company is Rs 25.84 per share. At current value, the price-to-book value of the company is 25.32.


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