Generic Product News
Lidocaine Topical Patch, 5%
Lidoderm (Endo Pharmaceuticals Inc and Teikoku Seiyaku Co Ltd)
Actavis, Inc, has launched a generic version of Lidoderm as part of an exclusive settlement agreement with Endo Pharmaceuticals Inc and Teikoku Seiyaku Co LD. The patch is a local anesthetic indicated for the relief of post-shingles pain. Actavis has commenced product shipment, and believes that, under applicable Hatch–Waxman rules, it is entitled to 180 days of marketing exclusivity.
Topical Patch: 5%
For More Information: www.actavis.com
Clonidine HCl Extended-Release Tablets
Par Pharmaceutical Companies Inc
Par Pharmaceutical Companies, Inc, has received final approval from the FDA for its abbreviated new drug application for clonidine hydrochloride extended-release tablets. It is the generic version of Concordia’s Kapvay and is indicated for the treatment of attention deficit hyperactivity disorder as monotherapy or as adjunctive therapy to stimulant medications. The tablets are contraindicated in patients with a known hypersensitivity to clonidine. Par has commenced shipping the 0.1-mg strength of the product.
Tablets: 0.1 mg
For More Information: www.parpharm.com
Nitroglycerin Lingual Spray
Nitrolingual Pumpspray (Arbor Pharmaceuticals Inc)
Perrigo Company has received final approval for its abbreviated new drug application for nitroglycerin lingual spray, 400 mcg/spray, the generic equivalent to Arbor Pharmaceuticals Inc’s Nitrolingual Pumpspray. It is indicated for the acute relief of an attack or for prophylaxis of angina pectoris due to coronary artery disease. The recommended use is 1 or 2 sprays administered on or under the tongue during anginal attack. Perrigo has commenced shipment of the product.
Spray: 400 mcg/spray
For More Information: www.perrigo.com
Marketed by: Mylan Pharmaceuticals Inc
Compare to: Zomig Tablets (IPR Pharmaceuticals Inc)
Indication: Mylan Pharmaceuticals Inc, a subsidiary of Mylan Inc, has received final approval from the FDA for Zolmitriptan Tablets, a generic version of IPR Pharmaceuticals Inc’s Zomig Tablets. It is available in 2.5- and 5-mg strengths. It is indicated for the acute treatment of migraine with or without aura in adults in cases where a clear diagnosis of migraine has been established. It is not indicated for the prevention of migraine attacks or the treatment of cluster headaches.
Dosage Form: Tablets: 2.5 mg, 5 mg
For More Information: www.mylan.com