Generic Product News (February 2015)

Mylan, Inc

Compare to: Vivelle-Dot (Novartis Pharmaceuticals Corporation)

Indication: Mylan has announced the US launch of its estradiol transdermal system, USP, which is the generic version of Novartis’ Vivelle-Dot. Mylan received final FDA approval of its Abbreviated New Drug Application for this product, which is indicated for the treatment of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, hypoestrogenism due to hypogonadism, castration, or primary ovarian failure, and the prevention of postmenopausal osteoporosis.

Dosage Form: Transdermal: 0.025 mg/ day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (twice weekly)

For More Information: www.mylan.com

Celecoxib CapsulesMarketed by: Teva Pharmaceutical Industries Ltd

Compare to: Celebrex capsules (Pfizer)

Indication: Teva Pharmaceutical Industries Ltd has announced the launch of celecoxib capsules, a generic equivalent of Pfizer’s Celebrex capsules. Celecoxib capsules are a nonsteroidal anti-inflammatory drug indicated for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain, and primary dysmenorrhea. Patients should be given the lowest effective dose for the shortest duration of time, consistent with the individual patient’s treatment goals.

Dosage Form: Capsules: 50, 100, 200, and 400 mg

For More Information: www.tevagenerics.com

Fexofenadine HCl TabletsMarketed by: Wockhardt USA LLC

Compare to: Allegra tablets (Chattem, Inc)

Indication: Wockhardt USA LLC has introduced its newest private-label OTC medication, fexofenadine HCl, in small, easy-to-swallow tablets. It is the generic equivalent of Chattem’s Allegra tablets. Fexofenadine HCl tablets are indicated for the treatment of allergies, hay fever, and runny nose. The product will be ready to ship in June 2015.

Dosage Form: Tablets: 60 and 180 mg

For More Information: www.wockhardtusa.com

Estradiol Transdermal SystemMarketed by: Sandoz

Compare to: Vivelle-Dot (Novartis Pharmaceuticals Corporation)

Indication: Sandoz has announced the US market introduction of estradiol transdermal system, an authorized generic version of Vivelle-Dot, which is marketed by Novartis Pharmaceutical Corporation. It is indicated for the treatment of certain menopausal symptoms and for the prevention of postmenopausal osteoporosis. Sandoz will market the product in the same strengths as Vivelle-Dot.

Dosage Form: Transdermal: 0.025 mg/ day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day

For More Information: www.us.sandoz.com

Valsartan Tablets, USPMarketed by: Teva Pharmaceutical Industries Ltd

Compare to: Diovan (Novartis Pharmaceuticals)

Indication: Teva Pharmaceutical Industries Ltd has announced the approval and launch of Valsartan Tablets, the generic equivalent of Novartis Pharmaceuticals’ Diovan. Valsartan Tablets are an angiotensin II— receptor blocker indicated for the treatment of hypertension or heart failure.

Dosage Form: Tablets: 40, 80, 160, and 320 mg

For More Information: www.tevagenerics.com

Linezolid Injection

Marketed by: Teva Pharmaceutical Industries Ltd

Compare to: Zyvox Injection (CP Pharmaceuticals International)

Indication: Teva Pharmaceuticals Industries Ltd has announced the introduction and availability of linezolid injection. The product is AP-rated and bioequivalent to Zyvox Injection. Linezolid injection is an oxazolidinone-class antibacterial indicated for the treatment of nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium injections.

Dosage Form: Injection: 600 mg

For More Information: www.tevagenerics.com

Clobetasol Propionate Spray, 0.05%

Marketed by: Perrigo Company plc

Compare to: Clobex Spray, 0.05% (Galderma Laboratories, LP)

Indication: Perrigo Company plc has launched clobetasol propionate spray, 0.05%, the generic equivalent of Clobex Spray, 0.05%. Clobetasol propionate spray, 0.05%, is indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% of the body’s surface area, in adults 18 years or older. Perrigo was the first generic filer, and is entitled to 180 days of generic exclusivity.

Dosage Form: Topical spray: 0.05%

For More Information: www.perrigo.com

Testosterone Gel 1.0%

Marketed by: Perrigo Company PLC

Compare to: AndroGel 1.0% (AbbVie, Inc)

Indication: Perrigo Company plc has launched testosterone gel 1.0%, an AB-rated therapeutic equivalent of AndroGel 1.0%. Testosterone Gel 1.0% is indicated to treat adult males who have low or no testosterone. The FDA previously concluded that Perrigo’s testosterone product is therapeutically equivalent to AbbVie’s AndroGel 1.0%, and can be substituted with the full expectation that it will produce the same clinical effect and safety profile as AndroGel 1.0%, when used under the conditions specified in the labeling.

Dosage Form: Topical gel: 1.0%

For More Information: www.perrigo.com