Generic Product News (June 2019)

JUNE 14, 2019


ERLOTINIB HYDROCHLORIDE TABLETS
MARKETED BY:
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




AMBRISENTAN
MARKETED 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 SPRAY
MARKETED 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 TABLETS
MARKETED 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

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