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General product news: August 2022

August 24, 2022 by admin

This month’s new generic includes vilazadone tablets, leuprolide acetate injection, and oxcarbazepine tablets.

Vilazodone tablets

Marketed by Accord Healthcare

Compare with: 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 doses of 10, 20 and 40 mg. The drug is a serotonin modulator and works by increasing the amount of serotonin in the brain and nervous system. Vilazodone is contraindicated for individuals taking monoamine oxidase inhibitors, and it should not be used with other drugs that increase serotonin levels through various mechanisms. Vilazodone can cause diarrhea, insomnia and nausea.

FOR MORE INFORMATION:

accordhealthcare.us

Leuprolide Acetate Injection

Marketed by Eugia Pharma Specialties

Compare with: Lupron Injection

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

FOR MORE INFORMATION:

aurobindo.com

Oxcarbazepine Tablets

Marketed by Camber Pharmaceuticals

Compare with: 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 monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults, as well as monotherapy in the treatment of partial-onset seizures in children 4 years of age and older. In addition, it is indicated as adjunctive therapy for children 2 years of age and older with partial onset seizures. The tablets are available in the dosages of 150, 300 and 600 mg in bottles of 100 pieces.

FOR MORE INFORMATION:

camberpharma.com

Doxycycline Hyclate Capsules

Marketed by Alembic Pharmaceuticals

Compare with: Vibramycin

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

FOR MORE INFORMATION:

alembicusa.com

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