Recent Generic Approvals

FDA approves generic cartridges for Apokyn Pen for Parkinson’s.

The FDA has approved an abbreviated new drug application for apomorphine hydrochloride cartridges, the first generic equivalent for use with Supernus Pharmaceuticals’ Apokyn. This approval is for Sage Chemical’s application of the drug cartridges only, which are compatible for use with the Apokyn Pen, the brand-name pen injector. It is approved to treat loss of control of body movements in people with advanced Parkinson’s disease.

The FDA notes that patients still need a prescription for the Apokyn Pen and need to obtain through a specialty pharmacy.

The FDA has granted 180 days of competitive generic therapy exclusivity for the cartridge. The product is currently available, but TruPharma, Sage’s marketing partner, noted in a statement that there are limited quantities because of current manufacturing and supply chain constraints.

Amneal Pharmaceuticals gets four new generic approvals.

The FDA has approved four generic injectables products from Amneal Pharmaceuticals: dexamethasone sodium phosphate injection, azacytidine, carboprost tromethamine injection, and atropine sulfate injection.

Dexamethasone, a corticosteroid, and azacytidine, an equivalent of the anticancer therapy Vidaza, are both currently on the FDA drug shortage list. Vidaza, from Celgrene, is used to treat several myelodysplastic syndrome (MDS) subtype, including chronic myelomonocytic leukemia.

Carboprost is a generic version of the prostaglandin Hemabate from Pfizer, which is used aborting pregnancy between the 13th and 20th weeks of gestation and postpartum hemorrhage. Atroprine, which was granted competitive generic therapy status by the FDA, is used to stop severe or life-threatening muscarinic effects, such as low heart rate. It is also used to reduce saliva, mucus, or other secretions during a surgery, as well as treat spasms in the stomach, intestines, bladder, or other organs.

Nexus Pharmaceuticals gets FDA nod for generic of Erythrocin.

The FDA has approved the antibacterial erythromycin lactobionate for injection in single-dose vials developed by Nexus Pharmaceuticals. It is used to treat respiratory tract infections, skin and skin structure infections, diphtheria, pelvic inflammatory disease, and Legionnaire’s disease. It is also used to prevent attacks from rheumatic fever and endocarditis. It is a generic to Pfizer’s Erythrocin.

Erythromycin lactobionate for Injection will be available in cartons of five single-dose vials.

Amring gets approval for generic of Lamictal for epilepsy.

The FDA has approved Amring Pharmaceuticals’ generic lamotrigine, which is used to treat epilepsy. It a generic equivalent of Lamictal from GlaxoSmithKline. The Amring generic is available in 25 mg, 50 mg, 100 mg and 200 mg in bottles of 30 tablets.