Drug approved for relapsing forms of MS
The FDA approved Bafiertam (monomethyl fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
Bafiertam is a novel fumarate bioequivalent alternative to its prodrug dimethyl fumarate and has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway. Approval was based on bioavailability studies in healthy individuals comparing oral dimethyl fumarate delayed-release capsules to Bafiertam delayed-release capsules.
Labeling notes that because both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate, concomitant use with Bafiertam is contraindicated. Bafiertam can be initiated the day following discontinuation of either of these drugs. Bafiertam is a product of Banner Life Sciences.
Metformin extended-release products voluntarily recalled
Two companies are voluntarily recalling all lots of their metformin extended-release products, and three other companies are voluntarily recalling one or more lots because N-nitrosodimethylamine (NDMA) was detected during tests. NDMA is classified as a probable human carcinogen and is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables.
Apotex Corp. issued a voluntary nationwide recall of Metformin HCl Extended-Release Tablets, USP 500 mg. The FDA found that one lot of the drug showed results for NDMA levels in excess of the acceptable daily intake limit and recommended recalling the one tested lot. Apotex recalled the lot and out of an abundance of caution extended the recall to all lots of Metformin HCl Extended-Release Tablets in the US. The company stopped selling the product in the US in February 2019, and there remains only limited product on the market. The company has not received any reports of adverse reactions related to product use.
Amneal Pharmaceuticals is also voluntarily recalling all lots of Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg. Testing of 7 lots of this product showed NDMA amounts above acceptable levels. Out of an abundance of caution, the company extended the recall to all lots within expiry. Amneal's Metformin HCl Immediate Release Tablets, USP, are not affected by the recall.
FDA approves topical drug for pediatric onychomycosis
The FDA approved Jublia (efinaconazole) 10% topical solution for the treatment of onychomycosis of the toenails in patients age 6 years or older. The medication was previously approved only for adults age 18 and older.
The approval was based on data from a clinical trial evaluating the efficacy, safety, and pharmacokinetics of Jublia in 62 patients ages 6 to 16 years with mild-to-severe onychomycosis of the toenails. At week 52, 65% of patients achieved mycologic cure, with a 36.7% mycologic cure rate observed as early as week 12. Additionally, 40% of patients achieved complete cure, and 50% achieved clinical efficacy by week 52.
Jublia was well tolerated; the most common treatment-related adverse reaction was ingrown nails. Jublia is a product of Bausch Health and is provided with an integrated flow-through brush applicator. A prescription savings program is available for eligible patients.
First generic of Proventil HFA (albuterol sulfate) metered-dose inhaler
The FDA approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler (90 mcg/inhalation) for the treatment or prevention of bronchospasm in patients 4 years and older with reversible obstructive airway disease. It is also indicated for the prevention of exercise-induced bronchospasm in the same age group.
The most common adverse reactions associated with albuterol sulfate metered-dose inhaler (90 mcg/inhalation) include upper respiratory tract infection, rhinitis, nausea, vomiting, tachycardia, tremor, and nervousness.
The FDA's approval was granted to Cipla Limited, which plans to donate the product in this time of need.