Generic Product News (March 2015)

Pharmacy Times, March 2015 Central Nervous System, Volume 81, Issue 3

Read about the new generic products featured in March.

West-Ward Pharmaceuticals

Compare to: Mitigare (Hikma Pharmaceuticals LLC)

Indication: West-Ward Pharmaceuticals announces the launch of its colchicine 0.6-mg capsule for the prophylaxis of gout flares in adults. This is the first authorized generic (AG) colchicine 0.6-mg capsule, and it is the AG of Mitigare. Patients can take 1 capsule once or twice daily, without regard to meals.

Dosage Form: Capsules: 0.6 mg

For More Information: www.west-ward.com

Dexmethylphenidate Hydrochloride Extended-Release Capsules, CIIMarketed by: Teva Pharmaceutical Industries Ltd

Compare to: Focalin XR (Novartis AG Corp)

Indication: Teva Pharmaceuticals Ltd announces the introduction and availability of dexmethylphenidate hydrochloride extended-release (ER) capsules, CII, in a10-mg strength. The product is AB rated, and bioequivalent to Focalin XR ER capsules, CII. With the addition of this new strength, Teva now offers dexmethylphenidate HCl ER capsules in 5-, 10-, 15-, 30-, and 40-mg strengths.

Dosage Form: Capsules: 10 mg

For More Information: www.tevagenerics.com

Pantoprazole Sodium Delayed-Release Tablets, USPMarketed by: Camber Pharmaceuticals, Inc

Compare to: Protonix (Pfizer, Inc)

Indication: Camber Pharmaceuticals announces the launch of pantoprazole sodium delayed-release tablets, USP. It is the generic version of Pfizer’s Protonix tablets, and is used to treat gastroesophageal reflux disease and damage to the esophagus. The product is available from Camber in 20- and 40-mg tablets in 90-count bottles.

Dosage Form: Tablets: 20 and 40 mg

For More Information: www.camberpharma.com

Rizatriptan Benzoate TabletsMarketed by: Camber Pharmaceuticals, Inc

Compare to: Maxalt (Merck & Co)

Indication: Camber Pharmaceuticals announces that it has launched rizatriptan benzoate tablets in 5- and 10-mg strengths. It is the generic version of Maxalt tablets by Merck & Co, and is indicated for the treatment of migraine headaches. Camber’s rizatriptan benzoate product is available in 5- and 10-mg strengths in 18-count blister packs.

Dosage Form: Tablets: 5 and 10 mg

For More Information: www.camberpharma.com

Esomeprazole Magnesium Delayed-Release CapsulesMarketed by: Teva Pharmaceutical Industries Ltd

Compare to: Nexium Delayed-Release Capsules (AstraZeneca)

Indication: Teva Pharmaceutical Industries Ltd announces the FDA approval of esomeprazole magnesium delayed-release capsules, a generic equivalent of Nexium Delayed-Release Capsules. The product is a proton-pump inhibitor indicated for the treatment of gastroesophageal reflux disease, risk reduction of gastric ulceration associated with the use of nonsteroidal anti-inflammatory drugs, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions, including Zollinger- Ellison syndrome.

Dosage Form: Capsules: 20 and 40 mg

For More Information: www.tevagenerics.com

Nystatin Topical Powder, USPMarketed by: Vensun Pharmaceuticals, Inc

Compare to: Mycostatin Topical Powder (Delcor)

Indication: Vensun Pharmaceuticals, Inc, has announced the launch of Nystatin Topical Powder, USP, the generic equivalent of Mycostatin Topical Powder. The Vensun generic is AT-rated and therapeutically equivalent to Mycostatin Topical Powder. This medicine is an antifungal, primarily used to treat some types of fungal infections of the skin. The package insert contains detailed information about the indications, side effects, and warnings.

Dosage Form: Topical Powder: 100,000 USP units per gram in packaging sizes of 15-g, 30-g, and 60-g bottles.

For More Information: www.vensunrx.com

Diclofenac Sodium Topical Solution 1.5%Marketed by: Perrigo Company plc

Compare to: Pennsaid (Nuvo Research, Inc)

Indication: Perrigo Company plc has received final approval from the FDA on its Abbreviated New Drug Application for diclofenac sodium topical solution 1.5%, a generic version of Nuvo Research, Inc’s, Pennsaid. Perrigo has commenced shipping the product to its pharmacy customers. Diclofenac sodium topical solution 1.5% is indicated for the treatment of the signs and symptoms of osteoarthritis of the knee. The package insert contains detailed information about the indications, side effects, and warnings.

Dosage Form: Topical solution: 1.5%

For More Information: www.perrigo.com

Lamivudine TabletsMarketed by: Mylan, Inc

Compare to: Epivir-HBV Tablets (GlaxoSmithKline)

Indication: Mylan, Inc, has launched its lamivudine tablets, 100 mg, which is the generic version of GlaxoSmithKline’s Epivir-HBV. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. In patients with unrecognized or untreated HIV, resistance may emerge while treating hepatitis B with lamivudine.

Dosage Form: Tablets: 100 mg

For More Information: www.mylan.com