Generic Product News (November 2014)

Atovaquone Oral Suspension, USPMarketed by: Amneal Pharmaceuticals

Compare to: Mepron Oral Suspension (GlaxoSmithKline)

Indication: Amneal Pharmaceuticals has launched atovaquone oral suspension USP, a first-to-market generic medication that is an AB-rated therapeutic equivalent of GlaxoSmithKline's Mepron Oral Suspension. Atovaquone oral suspension USP is available in 750 mg/5 mL strength, and comes packaged in 210-mL (8 fl oz) bottles. It is indicated for the prevention of Pneumocystis jiroveci pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole. It is also indicated for the acute oral treatment of mild to moderate Pneumocystis pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.

Dosage Form: Oral suspension: 750 mg/5 mL

For More Information: www.amneal.com

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE TABLETS

Marketed by: Perrigo Company

Compare to: Advil Congestion Relief Tablets (Pfizer Consumer Health Care)

Indication: Perrigo Company announced that it has received final approval from the FDA for its abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets, the OTC store brand equivalent of Advil Congestion Relief Tablets. Perrigo expects to begin shipments of the product prior to the upcoming cough, cold, and flu season. Ibuprofen and phenylephrine hydrochloride tablets are indicated for the relief of sinus pressure, nasal swelling and congestion, and headache.

Dosage Form: Tablets: 200 mg/10 mg

For more information: www.perrigo.com

DEXMEDETOMIDINE HYDROCHLORIDE INJECTION

Marketed by: Sandoz, Inc

Compare to: PRECEDEX (Hospira)

Indication: Sandoz has announced the US market introduction of its dexmedetomidine hydrochloride injection, a generic version of Hospira's PRECEDEX. Dexmedetomidine hydrochloride injection is indicated for sedation of initally intubated and mechanically ventilated patients during treatment in an intensive care setting, and the sedation of nonintubated pateints prior to and/or during surgical and other procedures. Sandoz is marketing dexmedetomidine hydrochloride injection in 200 mcg/2 mL (100 mcg/mL) glass vials.

Dosage Form: Injectable: 200 mcg/2 mL (100 mcg/mL)

For More Information: www.us.sandoz.com

LAMIVUDINE AND ZIDOVUDINE TABLETS, USPMarketed by: Mylan, Inc.

Compare to: Combivir (Viiv Healthcare)

Indication: Mylan, Inc, has announced the launch of its lamivudine and zidovudine tablets, USP, 150 mg/300 mg, which is the generic version of Viiv Healthcare's Combivir. Mylan received final approval from the FDA of its Abbreviated New Drug Application for this product, which is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. Mylan has begun shipping this product.

Dosage Form: Tablets: 150 mg/300 mg

For More Information: www.mylan.com