First Generic Approved for Prolensa

Lupin Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved its generic for Prolensa^™ (bromfenac – Bausch Health) Ophthalmic Solution, 0.07% in August 2023. Although generics already are marketed in the U.S. for other strengths of bromfenac ophthalmic solutions, Lupin has 180 days of exclusivity because it is the first to have approval for Prolensa’s strength. It is used to treat pain and inflammation in patients who have had surgery for cataracts. The typical dose is one drop in the affected eye once each day from the day before the procedure until 14 days after it. No information about launch or pricing is available for the generic. According to IQVIA, Prolensa’s U.S. sales amounted to $185 million for the 12-month period that ended on Sept. 30, 2023.

MedWatch Updates

Levetiracetam and Clobazam

In a Safety Communication that was issued on Nov. 28, 2023, the FDA advised patients, caregivers and prescribers that taking levetiracetam or clobazam to control seizures may cause a very rare side effect known as drug reaction with eosinophilia and systemic symptoms (DRESS). Commonly beginning as fever, skin rash and/or swollen lymph nodes, DRESS can result in organ damage. Both drugs are available as generics and under different brand names. The FDA is instructing manufacturers of the drugs to include more details about the possibility of DRESS on the labeling of the products. Patients and their caregivers should be alert for the symptoms of DRESS and get emergency medical help immediately if they think DRESS reactions are occurring, especially if symptoms begin within two weeks to eight weeks after starting one of the drugs. Prescribers should advise patients and caregivers about symptoms of DRESS and recommend other treatments, if needed, for patients who may be at risk. However, patients should not stop using the drugs unless their healthcare providers switch them to different ones. Please see the FDA’s notice for more information that includes a list of the affected drug names. 

CAR-T Therapies

Separately, the FDA also warned on Nov. 28, 2023, about the possibility that using any of the chimeric antigen receptor (CAR) T cell therapies may increase the risk of having a second cancer. Two of the drugs– Abecma^® (idecabtagene vicleucel) and Carvykti^® (ciltacabtagene autoleucel) are directed at B-cell maturation antigen (BCMA), and four others – Breyanzi^® (lisocabtagene maraleucel), Kymriah^® (tisagenlecleucel), Tecartus^® (brexucabtagene autoleucel) and Yescarta^® (axicabtagene ciloleucel) target cluster of differentiation (CD)19. BCMA and CD19 are associated with B-cell cancers. The drugs are tailored to each patient by collecting and then altering some of the patient’s T cells so that they bind specifically to BCMA or CD19. When the modified CAR-T cells are infused back into the patient, they inactivate the target protein, destroying the cancer cells that produce it. Some patients who received CAR-T therapy have developed T-cell malignancies and some have died. The FDA is advising that all patients be monitored closely while it investigates further. Here is more information.