Generic Product News: May 2023

Pharmacy TimesMay 2023
Volume 89
Issue 5

Products include an antidepressant and treatment for hypertension.

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

From: Alembic Pharmaceuticals

Compare To: Rexulti tablets

The FDA has tentatively approved a new drug application from Alembic Pharmaceuticals to market brexpiprazole tablets in 0.25-, 0.5-, 1-, 2-, 3-, and 4-mg strengths in the United States. Brexpiprazole is a generic antidepressant that is therapeutically equivalent to reference drug Rexulti (Otsuka Pharmaceutical Co, Ltd) in the same strengths. Brexpiprazole tablets are indicated as adjunctive therapy to antidepressants for patients with major depressive disorder and schizophrenia. In December 2022, brexpiprazole tablets had an estimated market size of $1.6 billion, according to data from IQVIA.

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Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg

From: Alembic Pharmaceuticals

Compare To: Minipress capsules

The FDA has approved Alembic Pharmaceuticals’ abbreviated new drug application for prazosin hydrochloride capsules in 1-, 2-, and 5-mg strengths. The drug is the generic form of reference drug Minipress capsules (Pfizer Inc) in the same strength. Prazosin hydrochloride is indicated for the treatment of hypertension and can reduce risk of serious cardiovascular events, including strokes. Its most common adverse effects include dizziness, drowsiness, headaches, heart palpitations, low energy, nausea, and weakness. By December 2022, prazosin hydrochloride had an estimated market value of $50 million, according to data published by IQVIA.

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Apixaban tablets, 2.5 and 5 mg

From: Zydus Lifesciences

Compare To: Eliquis tablets

The FDA has approved apixaban tablets in 2.5 and 5 mg. The tablets are indicated for the prevention and management of blood clots, helping to reduce the risk of blood clots and strokes in patients with atrial fibrillation. They can also lower the risk of blood clot formation in the legs and lungs of those who have recently had hip or knee replacement surgery and prevent or treat blood clots in pulmonary and saphenous veins. Apixaban tablets are the generic version of listed drug Eliquis tablets (Bristol Myers Squibb). In 2022, apixaban tablets in 2.5- and 5-mg strengths had an estimated market value of more than $18 million, according to IQVIA.

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Linezolid for Oral Suspension, 100 mg/5 mL

From: Camber Pharmaceuticals

Compare To: Zyvox oral suspension

Camber Pharmaceuticals has announced the addition to its portfolio of linezolid for oral suspension in strength 100 mg/5 mL (150-mL bottle). Linezolid for oral suspension is an oxazolidinone antibiotic indicated for nosocomial pneumonia caused by Staphylococcus aureus and Streptococcus pneumoniae. The most common adverse events include diarrhea, dizziness, headaches, nausea, rashes, and vomiting. It is contraindicated in individuals with a known hypersensitivity to linezolid or other components of the formula and in patients taking a monoamine oxidase inhibitor. Linezolid for oral suspension 100 mg/5 mL is the generic version of the reference listed drug Zyvox, which is manufactured by Pfizer Inc.

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