Up until a week ago, Ranbaxy was banking that its generic version of Astellas’ enlarged prostate treatment Flomax was going to clear FDA and help boost the flailing company. But things appear to have gone awry for the Indian firm. On Wednesday, Ranbaxy representatives announced that they did not receive approval for the company’s tamsulosin, putting a kibosh on the launch of the drug.
Having nailed the coveted first-to-file status, Ranbaxy expected to hit the ground running on March 2, giving them an eight-week window to market their drug exclusively before the US patent expired. Analysts estimated that the company could have earned anywhere from $60 to $90 million in sales during the period in which it faced zero opposition.
Now all Ranbaxy can do is watch its stock sink as other pharmas gear up for their own Flomax clone launches. The lucky drug company turns out to be IMPAX Labs, which was successful in getting approval for their version of the drug.
"The approval of generic tamsulosin offers greater access to a widely used treatment for benign prostatic hyperplasia (BPH)," stated Gary Buehler, director of the FDA’s Office of Generic Drugs. "FDA is committed to making generic drugs available to patients, and these drugs must meet the same rigid standards as the brand name drugs."
It’s still uncertain why FDA didn’t green light Ranbaxy’s drug, but the latest news comes on the heels of a 2009 FDA letter blasting the firm for failing to meet US manufacturing standards at its overseas plants. No word on whether the two situations are related. And for the time being, Ranbaxy isn’t elaborating.