Generic Product News: August 2022

Pharmacy TimesAugust 2022
Volume 88
Issue 8

This month's generic product new features vilazadone tablets, leuprolide acetate injection, and oxcarbazepine tablets.

Vilazodone Tablets

Marketed by Accord Healthcare

Compare to: Viibryd

Accord Healthcare has launched vilazodone oral tablets as an equivalent to Viibryd (Allergan) for the treatment of major depressive disorder in adults. The products are offered in 10-, 20-, and 40-mg dose strengths. The medication is a serotonin modulator and works by increasing the amount of serotonin in the brain and the nervous system. Vilazodone is contraindicated for individuals who are taking monoamine oxidase inhibitors, and it should not be used with other drugs that elevate serotonin levels through different mechanisms. Vilazodone may cause diarrhea, insomnia, and nausea.


Leuprolide Acetate Injection

Marketed by Eugia Pharma Specialties

Compare to: Lupron Injection

Aurobindo Pharma has announced that Eugia Pharma Specialties has received final FDA approval for the manufacturing and marketing of leuprolide acetate injection 14 mg/2.8 mL multiple-dose vials for the treatment of symptoms associated with advanced prostate cancer. The injection is bioequivalent and therapeutically equivalent to the reference listed drug, Lupron injection 14 mg/2.8 mL from AbbVie. The market size of the product for the 12 months ending in April 2022 was $83 million, according to a statement from Aurobindo.


Oxcarbazepine Tablets

Marketed by Camber Pharmaceuticals

Compare to: Trileptal

Camber Pharmaceuticals has announced the addition of oxcarbazepine tablets to its portfolio. Oxcarbazepine tablets are the generic version of Oxtellar XR from Supernus Pharmaceuticals. The tablets are indicated as a monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults, as well as a monotherapy in the treatment of partial-onset seizures in children aged 4 years and older. Additionally, it is indicated as an adjunctive therapy for children aged 2 years and older with partial-onset seizures. The tablets are available in the 150-, 300-, and 600-mg dose strengths in 100- count bottles.


Doxycycline Hyclate Capsules

Marketed by Alembic Pharmaceuticals

Compare to: Vibramycin

The FDA has approved an abbreviated new drug application for Alembic Pharmaceuticals’ doxycycline hyclate capsules in the 50- and 100-mg dose strengths. It is therapeutically equivalent to the reference listed drug product, which is Vibramycin (Pfizer) capsules in the same strengths. Doxycycline is indicated for a wide variety of bacterial infections, including those that are caused by several gram- negative as well as gram-positive microorganisms. It is also indicated for the prophylaxis of malaria related to Plasmodium falciparum in individuals who travel for the short term, defined as less than
4 months, to areas with chloroquine- and/or pyrimethamine- sulfadoxine–resistant strains. It can also be used as an adjunctive therapy for acute intestinal amebiasis and severe acne.


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