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news.Discovery Laboratories has been frustrated once again in its efforts to gain FDA approval for its drug Surfaxin, for the treatment of a lung disorder in premature babies. Shares in the company fell by more than 10% in the wake of the latest FDA rejection.
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The FDA has informed the company in a preliminary communication that it still requires further information before it will grant its approval for the drug.
The company has previously received an “approvable” letter from the FDA for this drug, meaning that the agency considers the drug to be approvable but still requires more information. The company then responded to this request in a letter of its own that the company describes as “encyclopedic” in its thoroughness. However, the latest communication from the FDA signals that more information is still required before it will give the green light to Surfaxin.
The company expects to receive a letter from the FDA later this week that will give the details of the agencies remaining concerns.
Robert Capetola, president and chief executive, of Discovery commented. “Based upon the thoroughness of our response letter, we are optimistic that the FDA’s issues will center on a few select items that are capable of being addressed in an as timely and efficient manner as possible”.