Hyderabad-based Gland Pharma has received approval from USFDA for Fomepizole, a new competitive ADH inhibitor used to treat ethylene glycol and methanol poisoning. The stock rallied as much as 7%, making it the most it has gained in over five months.

In June, Gland Pharma announced that the USFDA had issued one observation following pre-approval inspection (PAI) for its seven products.

The pharma said that the observation was procedural, corrective and preventive actions would be submitted within the stipulated period.

The stock had plunged to a 52-week low in May after the company’s March quarter financial results were hit by issues such as plant shutdowns, a decline in the B2C business in India, and volatility in the rest of world tender business. The company’s revenue and net profit declined for the fourth straight quarter in March.

Shares of Gland Pharma are trading 4.4% higher at Rs 1,092. The stock is down 30% yearly and has more than halved over 12 months.