Generic Product News

Published Online: Friday, May 17, 2013
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Oxymorphone Hydrochloride Tablets, CII

Marketed by: Teva Pharmaceuticals
Compare to: Opana Tablets (Endo Pharmaceuticals)
Indication: 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.
Dosage Form: Tablets: 5 mg, 10 mg
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Marketed by: Sandoz
Compare to: Ortho-Cyclen (Janssen Pharmaceuticals)
Indication: 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.
Dosage Form: Tablets: 21 containing 0.25 mg norgestimate/0.035 mg ethinyl estradiol, 7 inactive tablets
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Buprenorphine HCL and Naloxone HCL Dihydrate SL Tablets
Marketed by: Actavis, Inc
Compare to: Suboxone (Reckitt Benckiser)
Indication: 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.
Dosage Form: Tablets: 2 mg/0.5 mg, 8 mg/2 mg
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Entacapone Tablets
Marketed by: Wockhardt
Compare to: Comtan (Orion Corporation and Novartis)
Indication: 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.”
Dosage Form: Tablets: 200 mg
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Related Articles
The FDA today approved Novartis’ secukinumab (Cosentyx), an interleukin-17A antagonist, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Gedeon Richter and Actavis today announced positive results from a phase 3 trial evaluating the efficacy and safety of cariprazine, an investigational atypical antipsychotic, in preventing relapse among schizophrenia patients.
Novartis announced that it has submitted New Drug Applications to the FDA for QVA149 and NVA237, investigational drugs for the long-term maintenance treatment of chronic obstructive pulmonary disease, following positive results from phase 3 trials of the drugs.
The FDA has acknowledged receipt of Actavis’s resubmitted New Drug Application for its investigational atypical antipsychotic, cariprazine, which is indicated for the treatment of patients with schizophrenia and manic or mixed episodes associated with bipolar I disorder.
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