Generic Product News (June 2019)

Mylan Pharmaceuticals

COMPARE TO: Tarceva

Erlotinib hydrochloride recently received FDA approval as a generic version of Tarceva for the treatment of metastatic non—small cell lung cancer in patients who have tumors with epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations detected by an FDA-approved test. Patients must also be receiving maintenance, first-line, second-line, or greater treatment following 1 prior chemotherapy regimen to be eligible for treatment.

DOSAGE FORM: Oral tablets

FOR MORE INFORMATION: mylan.com

AMBRISENTANMARKETED BY: Teva Pharmaceuticals

COMPARE TO: Letairis

The FDA has approved Teva Pharmaceuticals’ generic version of Gilead’s Letairis for the treatment of pulmonary arterial hypertension (PAH). Ambrisentan is an endothelin receptor antagonist that can help delay worsening of PAH. When combined with tadalafil, ambrisentan can help reduce the risk of disease progression and hypertension-related hospitalization and improve exercise ability.

DOSAGE FORM: Oral tablets

FOR MORE INFORMATION: tevapharm.com

NALAXONE HYDROCHLORIDE NASAL SPRAYMARKETED BY: Teva Pharmaceuticals

COMPARE TO: Narcan Nasal Spray

The FDA has given the go-ahead to Teva Pharmaceuticals to market its generic version of Narcan Nasal Spray, naloxone hydrochloride nasal spray. Although there are generic versions of injectable naloxone, this approval marks the first generic naloxone nasal spray. The move follows FDA meetings to address the opioid crisis and improve access to life-saving naloxone products, such as creating additional generic options.

DOSAGE FORM: Nasal spray

FOR MORE INFORMATION: tevapharm.com

METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE TABLETSMARKETED BY: Lannett Company Inc

COMPARE TO: Concerta

The FDA has granted approval to Lannett Company Inc to market its AB-rated generic version of Jannsen’s Concerta in 18-, 27-, 36-, and 54-mg doses. Methylphendiate hydrochloride extended-release tablets are stimulants used to treat attention-deficit/ hyperactivity disorder by increasing attention span and focus.

DOSAGE FORM: Oral tablets

FOR MORE INFORMATION: lannett.com