Generic Product News

Published Online: Wednesday, June 13, 2012
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Metformin Hydrochloride Immediate Release Tablets

Marketed by: Amneal Pharmaceuticals, LLS (Bridgewater, NJ)

Compared to: Glucophage (Bristol-Myers Squibb Company)

Indication: Amneal Pharmaceuticals, LLC, announced a new formulation for its Metformin Hydrochloride (HCl) Immediate Release Tablets with blackberry flavoring. The new flavor imparts a pleasant taste and aroma and mitigates the smell of nonflavored metformin. The change was implemented after the company evaluated customer feedback regarding the inherent smell of the active pharmaceutical ingredient. Metformin HCl Immediate Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes.

Dosage Form: Tablets: 500, 800, and 1000 mg

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Olanzapine Tablets

Marketed by: Dr. Reddy’s Laboratories (Hyderabad, India)

Compared to: Zyprexa (Eli Lilly and Company)

Indication: Dr. Reddy’s Laboratories announced the launch of Olanzapine Tablets, a bioequivalent generic version of Eli Lilly’s Zyprexa. Olanzapine Tablets are indicated for the treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar 1 disorder and maintenance treatment of bipolar 1 disorder, and treatment of manic or mixed episodes associated with bipolar 1 disorder as an adjunct to lithium or valproate.

Dosage Form: Tablets: 2.5, 5, 7.5, 10, 15, and 20 mg

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Gabapentin Oral Solution

Marketed by: Acella Pharmaceuticals (Alpharetta, GA)

Compared to: Neurontin (ParkeDavis), a division of Pfizer Inc

Indication: The FDA approved Acella Pharmaceuticals’ Gabapentin Oral Solution in 250-mg/5-mL strength as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients older than 12 years with epilepsy. Gabapentin Oral Solution is also indicated as adjunctive therapy in the treatment of partial seizures in children aged 3 to 12 years as well as for the management of postherpetic neuralgia in adults.

Dosage Form: Oral solution: each 5 mL of oral solution contains 250 mg of gabapentin

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Doxycycline Hyclate Delayed-Release Tablets USP

Marketed by: Mylan Pharmaceuticals Inc (Morgantown, WV), a subsidiary of Mylan Inc (Canonsburg, PA)

Compared to: Doryx (Mayne Pharma)

Indication: Mylan Pharmaceuticals Inc announced the launch of Doxycycline DelayedRelease Tablets, a tetracycline-class antimicrobial. Doxycycline Delayed-Release Tablets are indicated for the treatment of Rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, and anthrax. It is also indicated for alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria.

Dosage Form: Tablets: 150 mg

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Related Articles
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.
Janssen announced today that the FDA has granted Priority Review designation to its New Drug Application (NDA) for paliperidone palmitate, a 3-month atypical antipsychotic for treating schizophrenia in adults.
Mylan has announced the US launch of its lamivudine tablets, the generic version of GlaxoSmithKline's hepatitis B virus (HBV) treatment, Epivir-HBV.
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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