Oxymorphone Hydrochloride Tablets, CII
Opana Tablets (Endo Pharmaceuticals)
Teva Pharmaceuticals announced the introduction and availability of oxymorphone hydrochloride tablets, CII. It is AB rated and bioequivalent to Endo Pharmaceuticals’ Opana. It is indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate. The tablets should be administered on an empty stomach, at least 1 hour prior to or 2 hours after eating.
Tablets: 5 mg, 10 mg
For More Information: www.tevagenerics.com
Ortho-Cyclen (Janssen Pharmaceuticals)
Sandoz announced the FDA approval of Estarylla (norgestimate and ethinyl estradiol tablets), a generic equivalent of the oral contraceptive Ortho-Cyclen. It is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Sandoz is marketing Estarylla in dosage regimens identical to that of the originator product, and it must be taken exactly as directed at intervals not to exceed 24 hours.
Tablets: 21 containing 0.25 mg norgestimate/0.035 mg ethinyl estradiol, 7 inactive tablets
For More Information: www.us.sandoz.com
Buprenorphine HCL and Naloxone HCL Dihydrate SL Tablets
Suboxone (Reckitt Benckiser)
Actavis, Inc, has received approval from the FDA on its Abbreviated New Drug Application for buprenorphine HCl and naloxone HCl dihydrate tablets, the generic equivalent to Reckitt Benckiser Healthcare’s Suboxone. It is indicated for the maintenance treatment of opioid dependence. Actavis intends to begin shipping buprenorphine HCL and naloxone HCL hydrate SL tablets immediately.
Tablets: 2 mg/0.5 mg, 8 mg/2 mg
For More Information: www.actavis.com
: Comtan (Orion Corporation and Novartis)
Pharmaceutical and biotechnology company Wockhardt has received FDA approval for a generic version of Comtan (entacapone). The entacapone tablets are available in a 200-mg formulation. Entacapone tablets are indicated for the treatment of idiopathic Parkinson’s disease as an adjunct to levodopa and carbidopa therapy in patients who experience the signs and symptoms of end-of-dose “wearing-off.”
Tablets: 200 mg
For More Information: www.wockhardt.com