Bupropion hydrochloride, currently available as an antidepressant (Wellbutrin - Medical Letter, 31:97, 1989; Wellbutrin SR), is now being marketed in a sustainedrelease formulation as Zyban (Glaxo Wellcome) for use as an aid in smoking cessation.

The FDA has approved (Giapreza) (La Jolla), an IV formulation of synthetic angiotensin II, to increase blood pressure in adults with septic or other vasodilatory shock, such as anaphylactic or neurogenic shock. Angiotensin is a naturally occurring peptide hormone in the renin-angiotensin-aldosterone system (RAAS). (Giapreza) is the first synthetic angiotensin II product to become available in the US.

Clozapine (Clozaril - Sandoz), a dibenzodiazepine antipsychotic drug that has been available in Europe for many years, was recently approved for marketing by the US Food and Drug Administration. Because of its toxicity, the labeling for clozapine recommends using the drug only for schizophrenic patients who have not responded adequately to standard antipsychotic drugs or have had intolerable adverse effects.

Entacapone (Comtan), a catechol-O-methyltransferase (COMT) inhibitor, has been approved by the FDA for adjunctive use with levodopa/carbidopa in patients with Parkinson's disease who have end-of-dose "wearing off"symptoms.

An orally dissolving, immediate-release tablet formulation of carbidopa/levodopa (Parcopa - Schwarz) that can be taken without water is now available for treatment of Parkinson's disease.

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...

Tetrabenazine (Xenazine - Ovation Pharmaceuticals), an old drug first synthesized 50 years ago for treatment of schizophrenia, was recently approved by the FDA for the treatment of chorea associated with Huntington's disease. It has been available in other countries for decades.

Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in adults with Parkinson’s disease (PD) who experience "off" episodes. It is the third COMT inhibitor to be approved for this indication; tolcapone (Tasmar, and generics) and entacapone (Comtan, and generics) were approved earlier. Opicapone has been available in Europe since 2016.

The FDA has approved an extended-release fixed-dose combination of dextromethorphan and bupropion (Auvelity – Axsome) for treatment of major depressive disorder (MDD) in adults.