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Pharmacy Times
Generic Product News and Generic News
Marketed by:
Sandoz Inc (Princeton, NJ)
Compared to:
Dovonex (Warner Chilcott)
Indication:
Sandoz announced the introduction of calcipotriene solution 0.005%, a generic equivalent of Dovonex Scalp Solution, 0.005%, in the United States. Calcipotriene is a synthetic vitamin D3 derivative, and is used as a topical solution to treat moderately severe chronic psoriasis of the scalp. According to the National Institutes of Health, as many as 7.5 million people in the United States have psoriasis, an autoimmune disease that is associated with serious health conditions, including diabetes and heart disease.
Dosage Form:
0.005% solution in 60-mL plastic bottles
For More Information:
Morphine Sulfate Oral Solution CII
Marketed by:
Roxane Laboratories Inc (Columbus, OH), a subsidiary of Boehringer Ingelheim Corp
Indication:
Roxane Laboratories Inc announced the new drug application approval of morphine sulfate oral solution CII, 100 mg/5 mL (20 mg/mL) 30- and 120-mL bottles by the FDA. The product is indicated for the relief of moderate-tosevere acute and chronic pain in opioid-tolerant patients. Roxane Laboratories’ morphine sulfate oral solution CII, 100 mg/5 mL (20 mg/mL) is the only FDA-approved morphine sulfate oral solution CII available at this concentration.
Dosage Form:
Oral Solution: For the 10-mg/5-mL or 20-mg/5-mL strengths, each milliliter contains 2 or 4 mg of morphine sulfate. For the 100-mg/5-mL (20-mg/mL) strength, each milliliter contains 20-mg of morphine sulfate.
For More Information:
800-962-8364
Oxaliplatin Injections
Marketed by:
Caraco Pharmaceutical Laboratories Ltd (Detroit, MI)
Compared to:
Eloxatin (sanofi-aventis US LLC)
Indication:
Caraco Pharmaceutical Laboratories Ltd launched oxaliplatin injections. These 50- and 100-mg oxaliplatin injections, which are therapeutically equivalent to Eloxatin from sanofi-aventis, received approval from the FDA for Sun Pharma’s abbreviated new drug application. Oxaliplatin is an anticancer agent used in the treatment of colon and rectal cancer.
Dosage Form:
Single-use vials of 50 or 100 mg oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution.
For More Information:
Losartan Potassium Tablets USP
Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to:
Cozaar (E.I. du Pont de Nemours and Co)
Indication:
Teva Pharmaceuticals announced the introduction and availability of losartan potassium tablets USP. This product is AB-rated and bioequivalent to Cozaar. Losartan potassium tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents, including diuretics. The tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients. Losartan potassium tablets are available in a 25-mg strength, in bottle sizes of 90 and 1000, and 50- and 100- mg strengths, in bottle sizes of 30, 90, and 1000.
Dosage Form:
Tablets: 25, 50, and 100 mg
For More Information:www.tevausa.com
888-TEVA USA (888-838-2872)
Tamsulosin Hydrochloride
Marketed by:
Global Pharmaceuticals (Chalfont, PA), the generic division of Impax Laboratories Inc
Compared to:
Flomax (Boehringer Ingelheim)
Indication:
Impax Laboratories Inc announced that the FDA granted final approval of the company’s abbreviated new drug application for the generic version of Flomax (tamsulosin hydrochloride) 0.4-mg capsules. The company also announced that shipment would commence through Global Pharmaceuticals, Impax’s generic division. Tamsulosin hydrochloride is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia. Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension.
Dosage Form:
Capsules: 0.4 mg
For More Information:
Marketed by:
Teva Pharmaceuticals (North Wales, PA)
Compared to:
Hyzaar (E.I. du Pont de Nemours and Co)
Indication:
Teva Pharmaceuticals announced the introduction and availability of losartan potassium and hydrochlorothiazide tablets. This product is AB-rated and bioequivalent to Hyzaar. The tablets are indicated for the treatment of hypertension. The tablets also are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to black patients. The tablets are available in 50-mg/12.5-mg and 100-mg/12.5- mg strengths, in bottle sizes of 30, 90, and 1000, and a 100-mg/25-mg strength in bottle sizes of 30 and 90.
Dosage Form:
Tablets: 50-mg/12.5-mg, 100-mg/12.5-mg, and 100-mg/25-mg strengths
For More Information:
888-TEVA USA (888-838-2872)
Generic News: What Does Health Care Reform Mean for Generics?
The recent passage of the bill to reform health care in the United States brings mixed reactions from the Generic Pharmaceutical Association (GPhA). Kathleen Jaeger, GPhA president and chief executive officer, recently issued a statement on the Health Care and Education Affordability Reconciliation Act of 2010, after its passage in the House of Representatives. Officials at GPhA see both positive and negative outcomes from the bill.
First, GPhA lists items such as wider patient access to health care and the closing of the Medicare doughnut hole in the pros column. “The good news is that more Americans will have health care coverage and more seniors will have access to generic medicines, thanks to a fix to the so-called doughnut hole,” stated Jaeger. “GPhA is pleased that the House has taken these steps to close the Medicare drug coverage gap and has eliminated the patent settlement provision that would have had the unintended consequence of delaying generic access.”
The unfortunate side of the health care reform bill is the lack of a true approval pathway for biogeneric medicines, according to GPhA. GPhA says that this will hinder many patients who desperately need lifesaving biopharmaceutical medicines but are unable to obtain access because of cost. As Jaeger explained, “the bill fails to infuse competition and choice into the health care system due to the excessive and unprecedented market exclusivity protections for the brand industry.” She continued, “while FDA has been given the flexibility to create a workable biogenerics approval pathway, the fact is that the brand market exclusivity protections in this bill…will keep affordable biogeneric medicines from patients for decades to come.”
Shortly after the passage of the bill in the House, it was also passed by the Senate, and the Health Care and Education Affordability Reconciliation Act of 2010 was signed into law by President Obama on March 30, 2010. It represents the most sweeping overhaul of the US health care system since the creation of Medicare in 1965. â–
