Wide Variety of Generics Get Approval From FDA.
NEW YORK -- A number of generic drugs from various manufacturers have been approved for the market.
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the Food and Drug Administration for teriflunomide tablets, 7 mg and 14 mg, a generic version of Aubagio Tablets, 7 mg and 14 mg, from Sanofi-Aventis U.S.
"With respect to 180-day generic drug exclusivity, we note that Glenmark was one of the first ANDA [Abbreviated New Drug Application] applicants to submit a substantially complete ANDA for teriflunomide tablets, 7 mg and 14 mg, with a paragraph TV certification. Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for teriflunomide tablets, 7 mg and 14 mg," the company said in a statement.
According to IQVIA sales data for the 12-month period ended September 2018, the Aubagio Tablets, 7 mg and 14 mg market achieved annual sales of approximately $1.6 billion.
Lupin introduced a generic version of Valeant's Xenazine (tetrabenazine) tablets, 12.5 mg and 25 mg, indicated for the treatment of chorea, or body spasms, associated with Huntington's disease. The company also released a generic version of GlaxoSmithKline's Mepron (atovaquone) oral suspension, 750 mg/5 mL, indicated for the prevention and treatment of Pneumocystis jirovecii pneumonia in adults and adolescents.
Lupin also received the FDA's blessing for clomipramine hydrochloride capsules in 25 mg, 50 mg and 75 mg dosage strengths. The product is a generic version of SpecGx's Anafranil capsules. It is indicated for the treatment of patients with obsessive-compulsive disorder. Anafranil capsules, 25 mg, 50 mg and 75 mg had a market value of about $109.6 million, according to IQVIA September 2018 data.
FDA also approved Lupin's potassium chloride for oral solution, 20 mEq. The product, which is a generic version of Pharma Research Software Solution's potassium chloride for oral solution, 20 mEq, is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich food or diuretic dose reduction is insufficient.
Teva is offering limited doses of the FDA approved generic version of Mylan's EpiPen (epinephrine injection) auto-injector 0.3 mg. Its generic version of the EpiPen Jr auto-injector 0.15 mg and an additional supply of Teva's generic version of the EpiPen auto-injector 0.3 mg are expected in 2019. The wholesale acquisition cost for the product is $300, the company said.
Hikma Pharmaceuticals USA rolled out a generic version of Halcion (triazolam) tablets, 0.125 mg and 0.25 mg, a benzodiazepine indicated for the short-term treatment of adults with