FDA Drug Approvals

The FDA has approved Fluzone High-Dose, an inactivated influenza virus vaccine for people age 65 and older to prevent disease caused by influenza virus subtypes A and B.

The FDA has approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablets. Donepezil hydrochloride is indicated for treating dementia related to Alzheimer’s disease.

The FDA has approved Zyprexa Relprevv (olanzapine) extended-release injectable suspension for treating schizophrenia in adults, Eli Lilly and Company has announced.

Mylan Inc. has announced it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for 1,000 mg levetiracetam tablets.

Octapharma USA has announced the FDA has approved Wilate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD).

The FDA has approved once-daily Seroquel XR (quetiapine fumarate) extended-release tablets as add-on treatment to antidepressants in adults with major depressive disorder (MDD).

The FDA has approved Zyprexa (olanzapine) in tablet form as an option for treating schizophrenia and manic or mixed episodes associated with bipolar disorder in adolescents ages 13 to 17.

The FDA has approved a 10 mcg dose formulation of Vagifem (estradiol vaginal tablets) to treat atrophic vaginitis due to menopause, a condition experienced by up to 75 percent of postmenopausal women.

The FDA has approved Kalbitor (ecallantide) to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

Merck has announced that the FDA has approved Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1,100 mg capsules), for over-the-counter treatment of frequent heartburn.