Generic Product News

Lansoprazole Delayed-Release Capsules USP

Marketed by:

Teva Pharmaceuticals (North Wales, PA)

Compared to:

Prevacid (Takeda Pharmaceuticals North America Inc)

Indication:

Teva Pharmaceuticals recently announced the availability and introduction of lansoprazole delayed-release capsules USP. The product is AB-rated and is bioequivalent to Prevacid Delayed-Release Capsules. Lansoprazole is a proton pump inhibitor and is indicated for the short-term treatment of duodenal ulcers and maintenance of healed duodenal ulcers; treatment of gastric ulcers; and the common symptoms of gastroesophageal reflux disease, including heartburn and erosive esophagitis.

Dosage Form:

Capsules: 15 and 30 mg

For More Information:

www.tevausa.com

888-TEVA USA (888-838-2872)

Tramadol ER

Marketed by:

Par Pharmaceutical Companies Inc (Woodcliff Lake, NJ)

Compared to:

Ultram ER (Ortho-McNeil)

Indication:

Par Pharmaceutical Companies Inc announced that it received final approval from the FDA for its abbreviated new drug application (ANDA) for the 100- and 200-mg strengths of tramadol ER. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the product. Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. Tramadol HCl ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Dosage Form:

Tablets: 100 and 200 mg

For More Information:

www.parpharm.com

Nizatidine Oral Solution

Marketed by:

Amneal Pharmaceuticals (Hauppauge, NY)

Compared to:

Axid Oral Solution (Braintree Laboratories Inc)

Indication:

Amneal Pharmaceuticals announced that it received FDA approval to manufacture nizatidine oral solution in the 15-mg/mL strength. It is an AA-rated, therapeutically equivalent alternative to Axid Oral Solution. The product is an anti-acid indicated in the treatment and prevention of heartburn and gastroesophageal reflux disease, as well as conditions associated with excess acid secretion. Nizatidine oral solution is the first available generic in oral solution form–Amneal will have 180 days of exclusivity to market the product. Nizatidine oral solution is a clear yellow, peppermint-flavored syrup, which will be sold in a 16-fl-oz/473-mL lightweight, ultraviolet-protected plastic bottle. The product does not require refrigeration.

Dosage Form:

Oral solution: 15 mg/mL

For More Information:

www.amneal.com

Marketed by:

Sandoz Inc (Princeton, NJ)

Compared to:

Cardene (EKR Therapeutics Inc)

Indication:

Sandoz recently announced the introduction of nicardipine, a generic equivalent of Cardene. Nicardipine is a calcium channel blocker that is indicated for the shortterm management of hypertension when oral treatment is not feasible or not desirable. The product is administered by injection. Sandoz will market nicardipine in 2.5-mg vials, the same as Cardene.

Dosage Form:

For injection: 2.5-mg vials

For More Information:

www.us.sandoz.com â–