FDA Warning Eclipses Sun, SPARC But Investors Stand Pat
This article was originally published in Scrip
Executive Summary
Shares of Sun Pharmaceutical Industries Ltd and Sun Pharma Advanced Research Company Ltd (SPARC) were pounded in early trade Dec. 21 on Indian bourses after the weekend announcement of an FDA warning letter for Sun's Halol site, though analysts appeared cautiously optimistic about the firm's bounce-back prospects despite the short-term pain.
You may also be interested in...
Baclofen Setback Forces Sun R&D Arm Towards Difficult Choices
Sun Pharma Advanced Research Company’s baclofen GRS has failed to meet its primary endpoint in a US Phase III study, posing several tough questions for the firm. It may have to advance partnering plans for some assets and also review its cash flow situation closely.
Keeping Track: New Submissions In Bladder Cancer, HCV And Diabetes; Avastin Label Expands
The latest drug development news and highlights from our FDA Performance Tracker.
SPARC Pins Hope On Halol Plant For Elepsia FDA Nod But Has Plan B
Sun Pharma’s research arm SPARC says it’s still convinced its Indian parent’s troubled Halol plant offers the shortest route to US regulatory approval for its epilepsy drug Elepsia and its glaucoma medicine Xelpros. US FDA clearances of both drugs have been stalled by manufacturing lapses at Sun Pharma’s factory. But SPARC says it has a manufacturing 'plan B' if necessary.