August 5, 2021

New Generic Approvals

The FDA recently issued several drug approvals for first-time generic medications. Some of these approvals impact workers’ comp populations, meaning that more cost-effective generics will soon be on the market to reduce drug spend on impacted claims.

Xeljanz® for Rheumatoid Arthritis

Xeljanz (tofacitinib) tablets were originally approved in 2012 and the product is indicated for the treatment of moderate-to-severe active rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis, a subset of juvenile idiopathic arthritis (JIA) in which more than four joints are affected during the first six months of illness.

In various industries, workers may develop certain forms of arthritis due to cumulative or acute trauma, or they may aggravate pre-existing forms of arthritis. This has led to an increase in specialty arthritis drugs making their way into workers’ comp, which is why drugs such as Xeljanz appear in claims.

Generic tofacitinib citrate tablets are now approved at 5 mg and 10 mg doses, though this generic approval does not apply to Xeljanz XR® extended relief tablets.

Aptiom® for Seizures

Aptiom (eslicarbazepine acetate) tablets were originally approved in 2013 and this product is indicated for the treatment of partial-onset seizures.

Many anticonvulsant drugs are relevant to workers’ comp, as they are often prescribed off-label for nerve pain. Furthermore, injured workers with traumatic brain injury (TBI) or other major head injuries may suffer from seizures. For these reasons, drugs such as Aptiom may appear in workers’ comp claims.

Generic eslicarbazepine acetate tablets are now approved at 200 mg, 400 mg, 600 mg, and 800 mg doses.

Brovana® for COPD

Brovana (arformoterol tartrate) inhalation solution was originally approved in 2006 and is indicated for long-term, twice daily administration for the maintenance of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

COPD can be considered an occupational illness for workers in certain industries or occupations, including miners, farm workers who are exposed to certain chemicals and pesticides, construction workers, sandblasters, and more.

Two generic approvals were granted for arfomoterol tartrate inhalation solution by the FDA – one from Axar Pharmaceuticals and one from Glenmark Pharmaceuticals.

Perforomist® for COPD

Perforomist (formoterol fumarate) inhalation solution was originally approved in 2001 for the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema.

Two generic approvals for formoterol fumarate inhalation solution were granted by the FDA – one from Teva Pharmaceuticals and one from Cipla Limited.

lockenvelopephone-handsetmenucross-circle