Generic Product News

Pharmacy TimesOctober 2014 Diabetes
Volume 80
Issue 10

Manufactured by: Sandoz and InnoPharma, Inc

Compare to: DACOGEN (Eisai Inc)

Sandoz announces the introduction of decitabine for injection, a generic version of Eisai Inc’s DACOGEN. InnoPharma, Inc, developed the generic formulation of decitabine for injection, and entered into an agreement with Sandoz, pursuant to which Sandoz will sell, market, and distribute decitabine for injection in the United States. Decitabine for injection is a prescription medicine for patients with myelodysplastic syndrome (MDS), including previously treated and untreated MDS and de novo (cause unknown) and secondary (treatment-related) MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

Dosage Form: Single-dose vials: 20 mL/50 mg

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Entecavir Tablets

Manufactured by: Teva Pharmaceutical Industries LTD

Compare to: Baraclude Tablets (Bristol- Myers Squibb)

Indication: Teva Pharmaceutical Industries Ltd announces the launch of entecavir tablets, the generic equivalent to Baraclude Tablets, marketed by Bristol-Myers Squibb. It will be available in 0.5- and 1-mg strengths. Entecavir tables are indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease.

Dosage Form: Tablets: 0.5 and 1 mg

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Risedronate Sodium Tablets USP

Manufactured by: Mylan Inc

Compare to: Actonel Tablets (Warner Chilcott)

Indication: Mylan Inc has launched risedronate sodium tablets USP, 150 mg, the generic version of Warner Chilcott’s Actonel Tablets. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

Dosage Form: Tablets: 150 mg

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Testosterone Gel 1%

Marketed by: Upsher-Smith Laboratories, Inc

Compare to: Vogelxo (testosterone) gel (Upsher-Smith Laboratories, Inc)

Indication: Upsher-Smith has announced the launch of Testosterone Gel, an authorized generic of Vogelxo (testosterone) gel. Vogelxo (testosterone) gel and Testosterone Gel are an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism and hypogonadotropic hypogonadism. Safety and efficacy of Vogelxo and Testosterone Gel in males younger than 18 years of age have not been established.

Dosage Form: Topical gel

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Amoxicillin Extended-Release Tablets

Manufactured by: Fera Pharmaceuticals, LLC

Compare to: Moxatag (Pragma Pharmaceuticals)

Indication: Fera Pharmaceuticals, LLC, is pleased to announce that it has been selected by Pragma Pharmaceuticals to launch Amoxicillin Extended-Release Tablets, the authorized generic for Moxatag. It is indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes infection in adults and pediatric patients 12 years and older.

Dosage Form: Tablets: 775 mg

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Rizatriptan Benzoate IR Tablets

Manufactured by: Heritage Pharmaceuticals, Inc

Compare to: Maxalt (Merck)

Indication: Heritage Pharmaceuticals, Inc, has announced the new product launch of Rizatriptan Benzoate IR tablets. This product is the AB-rated generic equivalent of Merck’s Maxalt. Rizatriptan, indicated for the treatment of migraine headaches, will be supplied in 5- and 10-mg dosage strengths in boxes of 3 × 6 blister cards.

Dosage Form: Tablets: 5 and 10 mg

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Acyclovir Ointment, USP

Marketed by: Amneal Pharmaceuticals

Compare to: Zovirax® Ointment 5% (Valeant Pharmaceuticals)

Indication: Amneal Pharmaceuticals has launched Acyclovir ointment, USP, in 5% strength. The product will be sold in 30-g tubes, and each gram of ointment contains 50 mg of acyclovir. The Amneal generic is an AB-rated therapeutic equivalent of Zovirax® Ointment 5%. The product is indicated for the management of (1) initial genital herpes and (2) limited non—lifethreatening mucocutaneous herpes simplex virus infections in immunocompromised patients.

Dosage Form: Topical ointment: 5%

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