Generic Product News: June 2022

This month's product news features acyclovir oral suspension, vigabatrin oral solution, and budesonide and formoterol bumarate dihydrate inhalation aerosol.

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%

Marketed by Sandoz

Compare To: Combigan

Sandoz has announced the generic version of AbbVie’s Combigan, a brimonidine tartrate/ timolol maleate ophthalmic solution in the 0.2%/0.5% strength. The eye drop combination is used to reduce eye pressure for individuals with ocular hypertension. It is an α-adrenergic receptor agonist with a β-adrenergic receptor inhibitor indicated to lower elevated intraocular pressure for individuals who need adjunctive or replacement therapies. The most common adverse events include allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging.

FOR MORE INFORMATION:

sandoz.com

Acyclovir Oral Suspension USP, 200 mg/5 mL

Marketed by Aurobindo Pharma Limited

Compare To: Zovirax

The FDA has granted its final approval to Aurobindo Pharma Limited’s acyclovir oral suspension USP in the 200-mg/5-mL strength. The abbreviated drug application listed the suspension as the generic equivalent to Zovirax from Mylan Pharmaceuticals Inc. It has 3 different indications, including the acute treatment of herpes zoster, known as shingles; the treatment of initial episodes and management of recurrent episodes of genital herpes; and the treatment of varicella zoster virus, known as chickenpox. It is considered an AB-rated generic equivalent by the FDA.

FOR MORE INFORMATION:

xiromed.com

Vigabatrin Oral Solution

Marketed by Lupin Limited

Compare To: Sabril

The FDA has approved the abbreviated new drug application for Lupin Limited’s vigabatrin. The oral solution is in the 500-mg strength and is the generic equivalent to Sabril from Lundbeck Pharmaceuticals LLC. The product will be manufactured at Lupin’s facility in Goa, India, and has estimated annual sales of $275 million in the United States. Sabril is indicated as an adjunctive therapy for individuals 2 years or older who have refractory complex partial seizures and have not responded to alternative treatment.

FOR MORE INFORMATION:

lupin.com

Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol

Marketed by Viatris Inc

Compare To: Symbicort

The FDA has approved budesonide and formoterol fumarate dihydrate inhalation aerosol, which is the first generic version of Symbicort from AstraZeneca. It is indicated for the treatment of individuals 6 years or older with asthma, as well as for the maintenance treatment of airflow instruction and reducing exacerbation for those with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema. The drug device combination includes a metered- dose inhaler that contains both drugs, reduces inflammation, and relaxes the muscles in the airways to improve breathing. The generic version of the drug should not be used to treat acute asthma attacks.

FOR MORE INFORMATION:

viatris.com