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Jubilant Pharmova Shares Gain On U.S. FDA Nod For Diagnostic Drug

Jubilant is eligible for 180 days of exclusivity through the ‘Competitive Generic Therapy’ designation from the U.S. FDA.

<div class="paragraphs"><p>Generics manufactured by Jubilant Pharmova (Source: Company website).&nbsp;</p></div>
Generics manufactured by Jubilant Pharmova (Source: Company website). 

Shares of Jubilant Pharmova Ltd. rose over 6% after its unit Jubilant Draximage Inc. got U.S. drug regulator's approval for its radiopharmaceutical diagnostic drug.

The U.S. Food and Drug Administration approved the company's abbreviated new drug application submitted for Technetium (Tc 99m) Sulfur Colloid Injection, according to an exchange filing.

Technetium Sulfur Colloid Injection is used in the localisation of metastatic lymph nodes in patients with breast cancer and melanoma, imaging of areas of the liver, spleen and bone marrow, and studies of esophageal transit, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents, according to its filing on Nov. 11.

“At Jubilant, we are glad to announce approval for Sulfur Colloid, which will improve availability of this critical radiopharmaceutical to patients and healthcare professionals," said Pramod Yadav, chief executive officer at Jubilant Radiopharma.

This approval is effective from Nov. 9 and Jubilant is eligible for 180 days of exclusivity through the ‘Competitive Generic Therapy’ designation from the U.S. FDA.

Shares of the company rose as much as 6.45% to Rs 438.9 apiece, the highest level since Oct. 3. It pared gains to trade 3.57% higher at Rs 427 apiece, as of 9:50 a.m. This compares to a 0.34% decline in the NSE Nifty 50 Index.

It has risen 14% on a year-to-date basis. Total traded volume so far in the day stood at 16 times its 30-day average. The relative strength index was at 60.

Out of the 28 analysts tracking the company, 20 maintain a 'buy' rating, four recommend a 'hold,' and four suggest a 'sell,' according to Bloomberg data. The average 12-month consensus price target implies an upside of 4.5%.