Lannet dismayed by delay to FDA’s decision

The FDA is tightening the potency specifications for levothyroxine sodium, used to treat underactive thyroid glands and other thyroid conditions, to ensure the drug retains its potency over its entire shelf life. The agency is adopting the recommendation of an advisory group of endocrinologists tightening the label specifications for potency range to 95-105%, in order to ensure its potency up to the expiry date of the product.

Lannett has had an exclusive distribution right with Jerome Stevens Pharmaceuticals, the manufacturer that holds the first FDA approval for levothyroxine sodium, and said that Jerome Stevens’ levothyroxine sodium products have always maintained stability throughout their 24-month expiration date. Jerome Stevens’ levothyroxine sodium products meet the new specifications for potency announced by FDA, the company added.

Arthur Bedrosian, president and CEO of Lannett, said: “We applaud the FDA’s decision to implement a recommendation from the advisory group of endocrinologists. We are dismayed, however, to see the FDA allow the regulated community an additional two years to meet the new standards.

“Our company continues to supply the market with Jerome Stevens’ Levothyroxine sodium products that meet the new standards today. There is no reason why the FDA should not require the new standards to be met immediately.

“Lannett will continue to do all that it can to communicate this information to the various healthcare professionals across the US, and we hope to capture a larger share of the market accordingly,” Bedrosian added.