FDA approves supplemental NDA for Januvia

WASHINGTON The FDA approved a supplemental new drug application for Merck’s Type 2 diabetes drug Januvia, citing new uses and additional warnings.

The pharmaceutical company, which produces several heart-related medications, had received feedback from patients taking Januvia (sitagliptin) experiencing health problems including anaphylaxis, angioedema and undesirable skin conditions. There had been reports that patients experienced the potentially fatal skin condition known as Stevens-Johnson Syndrome.

Januvia’s revised labeling will now indicate that patients with a history of hypertension should not use the drug. The company said, however, it could not establish a causal relationship to the drug or reliably estimate the frequency of the side effects.

The updated labeling additionally states that Januvia can be used as an initial therapy or add-on therapy with other medications, including metformin and sulfonylurea.