Generic Product News: September 2022

Pharmacy Times, September 2022, Volume 88, Issue 09

This month's generic product news features clorazepate dipotassium tablets, exemestane tablets, and paliperidone extended-release tablets.

Paliperidone Extended-Release Tablets

Marketed by Lupin Limited

Compare To: Invega

The FDA has approved Lupin Limited’s abbreviated new drug application for paliperidone extended-release tablets. The tablets come in 1.5-, 3-, 6-, and 9-mg strengths and are manufactured at the company’s facility in Goa, India. Paliperidone extended-release tablets are the generic equivalent of Invega extended-release tablets in the same strengths from Janssen Research and Development. Invega is indicated for the treatment of schizoaffective disorders and schizophrenia.

FOR MORE INFORMATION:

lupin.com

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

Marketed by Camber Corp

Compare To: Truvada

Camber Corp now offers emtricitabine and tenofovir disoproxil fumarate tablets. The generic is a combination of 2 drugs that are both HIV-1 nucleoside analogue reverse transcriptase inhibitors. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in both adults and children who weigh at least 17 kg. Camber is releasing the tablets in the 200-mg/300-mg strength in 30-count bottles.

FOR MORE INFORMATION:

camberpharma.com

Clorazepate Dipotassium Tablets

Marketed by ANI Pharmaceuticals

Compare To: Tranxene

The FDA approved an abbreviated drug application for clorazepate dipotassium tablets from ANI Pharmaceuticals. The generic equivalent of Tranxene from Recordati Rare Disease Inc, clorazepate dipotassium is indicated for the management of anxiety disorders. Common adverse events are depression, drowsiness, dry mouth, gastrointestinal complaints, headaches, and insomnia. Tranxene is indicated for the management of anxiety disorders and for the short-term relief of anxiety symptoms. It is also indicated for symptomatic relief of acute alcohol withdrawal and as an adjunctive therapy for partial seizures. The annual US market for clorazepate dipotassium is approximately $25.8 million, according to ANI Pharmaceuticals.

FOR MORE INFORMATION:

anipharmaceuticals.com

Exemestane Tablets

Marketed by Aurobindo Pharma Limited

Compare To: Aromasin

The FDA has approved an abbreviated new drug application for Aurobindo Pharma Limited’s exemestane tablets in the 25-mg strength. Exemestane tablets are the generic equivalent of Aromasin from Pfizer Inc and are indicated for the adjuvant treatment of postmenopausal women with estrogen receptor–positive early breast cancer. The tablets are also indicated for the treatment of postmenopausal women with advanced breast cancer whose disease has progressed following tamoxifen therapy. Exemestane is a steroidal irreversible aromatase inhibitor. The most common adverse events are fatigue, headaches, hot flashes, increased appetite, joint pain, nausea, sweating, and trouble sleeping.

FOR MORE INFORMATION:

aurobindousa.com