FDA Actions in Brief March 2011 (Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel)


Recent FDA Approvals (through February 2011) related to Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel

Azilsartan medoxomil (Edarbi, Takeda Pharmaceuticals North America) once-daily oral therapy was approved for the treatment of hypertension in adults for use alone and for use in combination with other antihypertensive medications.

Gabapentin (Gralise, Depomed) tablets were approved for once-daily treatment of post-herpetic neuralgia.

Rituximab (Rituxan, Genentech and Biogen Idec) was approved as a maintenance treatment for patients with advanced follicular lymphoma whose disease responded to initial treatment with Rituxan plus chemotherapy (induction treatment).

Hydroxyprogesterone caproate (Makena, Baxter Pharmaceutical Solutions) injection was approved to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least 1 spontaneous preterm birth.

The first product (Corifact, CSL Behring) intended to prevent bleeding in people with congenital Factor XIII deficiency was approved.

Microcyn-based dermatology HydroGel (Epicyn HydroGel, Oculus) was approved for the management of atopic dermatitis, radiation dermatitis, and other skin dermatoses.

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