New Mycophenolate Product Approved

Myhibbin (mycophenolate mofetil – Azurity Pharmaceuticals) ready-to-use oral suspension, 200mg/mL, was FDA-approved as a new formulation on May 1, 2024. The immunosuppressant is indicated for twice daily dosing to prevent organ rejection for patients as young as three months old who have received a heart, kidney, or liver transplant from a donor. Pediatric doses are based on the child’s weight. For adults, the total daily dose for a kidney transplant is 2Gm; for a heart or liver transplant, 3Gm (each divided into two equal parts). Myhibbin will be used along with other immunosuppressants, such as azathioprine or tacrolimus, with the first dose as soon after the transplant as possible. It should be given on an empty stomach, if possible; and it can be administered through a nasogastric (NG) tube for patients who cannot swallow the suspension. Mycophenolate mofetil has been available in the U.S. for nearly 30 years as the brand, CellCept^®, and more recently as generics for oral dosage forms — capsules, tablets, and powder for oral suspension — and also as an intravenous (IV) injection. A different formulation, mycophenolic acid, is marketed as delayed-release tablets under the brand name, Myfortic^® and generics. The two versions are absorbed differently, so mycophenolate mofetil products, including Myhibbin, are not interchangeable with mycophenolic acid. Because mycophenolate mofetil may cause fetal injuries or death, all products containing it have boxed warnings that discourage using it during pregnancy. Further boxed warnings outline the potential for developing certain cancers or severe infections among patients using it. Plans are to release Myhibbin in the U.S. during the second quarter of 2024, but its cost has not yet been announced. For its prescribing information, look here.

Generics Approved for Radicava Injection

Gland Pharma’s generic for Radicava^® (edaravone – Mitsubishi Tanabe Pharma) injection was approved by the FDA on May 6, 2024. At a recommended dose of 60mg, it is given by intravenous (IV) infusions on 28-day cycles to treat amyotrophic lateral sclerosis (ALS). Following one cycle of daily doses for the first 14 days and no treatment for the next 14 days, maintenance therapy consists of one dose per day on 10 of the first 14 days and no doses for the next 14 days. Gland Pharma intends to launch an edaravone injection in 2025 through an undisclosed marketing partner. It will be dispensed in 100mL bags containing either 30mg or 60mg of the drug. Cost also has not yet been announced. At least three other generics also were approved on the same day, but no information is available about plans for their introductions. The oral suspension form of the drug, Radicava ORS^®, remains brand-only. IQVIA estimated that Radicava’s annual sales in the U.S. were about $19 million.

Recall

On May 1, 2024, Rubicon Research Pvt. Ltd. recalled one lot of tramadol hydrochloride 50mg tablets after it was reported that a different medication, baclofen 10mg tablets, could be mixed in with one lot of tramadol hydrochloride 50mg tablets. Tramadol is an analgesic used to treat moderate to moderately severe pain. Baclofen is a skeletal muscle relaxant used to treat different types of muscle spasticity. Since baclofen has warnings for drowsiness and sedation patients with recalled prescriptions should consult with the dispensing pharmacy to ensure they have the right medication. For more details about the recall, see here.