Generic Product News
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
For More Information: us.sandoz.com
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
For More Information: www.tevagenerics.com
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
For More Information: www.mylan.com
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
For More Information: www.upsher-smith.com
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
For More Information: www.ferapharma.com
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
For More Information: www.heritagepharma.com
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%
For More Information: www.amneal.com