Generic Product News (July 2019)

MARKETED BY: Amerigen Pharmaceuticals

COMPARE TO: Bausch Health’s Cuprimine The FDA recently approved Amerigen Pharmaceuticals’ abbreviated new drug application (ANDA) for penicillamine capsules USP 250 mg. This is the first ANDA to be approved as a generic equivalent for Bausch Health’s Cuprimine. The capsules are indicated to treat Wilson disease, and cystinuria as well as in patients with active, severe rheumatoid arthritis in patients who have not responded to a trial of conventional therapy.

DOSAGE FORM: Capsules

FOR MORE INFORMATION: amerigenpharma.com

RANOLAZINE EXTENDED-RELEASE TABLETS

MARKETED BY: Teva Pharmaceutical Industries Ltd

COMPARE TO: Ranexa Teva Pharmaceutical Industries Ltd has launched a generic version of Ranexa extended-release tablets, 500 mg and 1000 mg, to treat chronic angina in patients in the United States. Ranolazine extendedrelease tablets block IKr and prolong the corrected QT interval. According to IQVIA data as of February 2019, ranolazine extended-release tablets have nearly $938 million in annual US sales.

DOSAGE FORM: Tablets

FOR MORE INFORMATION: tevapharm.com

BOSENTAN TABLETS

MARKETED BY: Hikma Pharmaceuticals

COMPARE TO: Tracleer Hikma Pharmaceuticals has launched bosentan tablets, 62.5 mg and 125.0 mg, through its US affiliate, Hikma Pharmaceuticals USA Inc. The tablets are indicated to treat pulmonary arterial hypertension (PAH) in adults to decrease clinical worsening and improve exercise ability. Studies establishing effectiveness included patients with etiologies of heritable or idiopathic PAH (60%), PAH linked with connective tissue diseases (21%), and PAH correlated with congenital heart disease with left-to-right shunts (18%).

DOSAGE FORM: Tablets

FOR MORE INFORMATION: hikma.com

CARBIDOPA AND LEVODOPA EXTENDEDRELEASE TABLETS USP

MARKETED BY: Alembic Pharmaceuticals

COMPARE TO: Sinemet The FDA recently granted Alembic Pharmaceuticals approval for carbidopa/ levodopa tablets to treat Parkinson disease. The extended-release tablets contain either 50 mg of carbidopa and 200 mg of levodopa, or 25 mg of carbidopa and 100 mg of levodopa. Both drugs work to increase dopamine levels in the brain, which are low in patients with Parkinson disease.

DOSAGE FORM: Tablets

FOR MORE INFORMATION: alembicpharmaceuticals.com