FDA actions in brief, July 2007

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Briefs of FDA actions/approvals of drugs, doses, and indications

Key Points

Levocetirizine (Xyzal, UCB/Sanofi-Aventis) was approved for the treatment of symptoms associated with seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children aged ≥6 years.

Somatropin (rDNA origin) injection (Norditropin, Novo Nordisk) was approved for the treatment of short stature in children with Noonan syndrome. This agent was previously approved for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone and for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet specific criteria.

Liquid fibrin sealant (Evicel, Omrix) was approved as an adjunct to hemostasis for use in patients undergoing vascular surgery when control of bleeding by standard surgical techniques is ineffective or impractical. This agent was previously approved as an adjunct to hemostasis in patients undergoing liver surgery.

FDA has approved estradiol gel 0.1% (Divigel, Upsher-Smith) for the treatment of moderate-to-severe hot flashes associated with menopause.

Tinidazole (Tindamax, Mission Pharmacal) was approved for the treatment of bacterial vaginosis. This agent was previously approved for the treatment of trichomoniasis, the intestinal infections giardiasis and intestinal amebiasis, and amebic liver abscess.

An extended-release formulation of zileuton (Zyflo CR, Dey/Critical Therapeutics) was approved for the prophylaxis and chronic treatment of asthma in adults and children aged ≥12 years.

An extended-release formulation of quetiapine (Seroquel XR, AstraZeneca) was approved for the treatment of schizophrenia in adult patients.

A new formulation of formoterol (Perforomist Inhalation Solution, Dey) was approved for the maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as chronic obstructive pulmonary disease (COPD).

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