Meitheal Pharmaceuticals – Recall of cisatracurium injection
Meitheal announced a voluntary, user level recall of one lot of cisatracurium injection because a product complaint revealed that a portion of one lot of cartons labeled as cisatracurium injection 10 mg/5 mL, containing ten vials per carton, contained ten vials mis-labeled as phenylephrine hydrochloride injection 100 mg/10 mL.
Apotmex – Recall of enoxaparin injection
Apotex announced a voluntary, consumer level recall of two lots of enoxaparin injection due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa.
Gocovri® (amantadine) – New indication
Adamas Pharma announced the FDA approval of Gocovri (amantadine), as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.
Nplate® (romiplostim) – New indication
The FDA approved Amgen’s Nplate (romiplostim), to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation.
Rapivab® (peramivir) – Expanded indication
The FDA approved Biocryst’s Rapivab (peramivir), for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days.trastuzumab-based regimen.