Generic Product News

Author:


Ciclopirox Shampoo, 1%


Marketed by:
Perrigo Company (Allegan, MI)

Compared to:

Loprox (Medicis, the Dermatology Co)

Indication:
Perrigo Company announced that it received final approval from the FDA to manufacture and market Ciclopirox Shampoo, 1%, a generic version of LOPROX Shampoo. Ciclopirox Shampoo, 1%, is an antifungal indicated for the treatment of seborrheic dermatitis of the scalp in adults. Patients should be advised to avoid contact with the eyes and mucous membranes. If contact does occur, the patient should rinse thoroughly with water.

Dosage Form:

Ciclopirox Shampoo, 1%, is supplied in 120- mL plastic bottles

For More Information:
www.perrigo.com


Ibutilide Fumarate Injection

Marketed by:
Bioniche Pharma (Lake Forest, IL)

Compared to:
Corvert (Pfizer Inc)

Indication:
Bioniche Pharma recently announced the launch of Ibutilide Fumarate Injection, the generic equivalent of Corvert from Pfizer Inc. Ibutilide fumarate injection is indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. This product has a boxed warning relating to proarrhythmic effects including potentially fatal arrhythmias (eg, polymorphic ventricular tachycardia) and consideration for use in patients with chronic atrial fibrillation.

Dosage Form:
0.1 mg/mL, 10-mL vials

For More Information:
www.bionichepharma.com


Oxcarbazepine Oral Suspension

Marketed by:

Sandoz Inc (Princeton, NJ)

Compared to:

Trileptal (Novartis Pharmaceuticals Corp)

Indication:
Sandoz recently announced the introduction of oxcarbazepine oral suspension, an authorized generic equivalent of the Novartis epilepsy treatment Trileptal, in the United States. Oxcarbazepine is an antiepileptic drug used as monotherapy or adjunctive therapy to treat partial seizures in adults, as monotherapy in the treatment of partial seizures in children aged 4 years and older with epilepsy, and as adjunctive therapy in children aged 2 years and older with epilepsy.

Dosage Form:
Oxcarbazepine oral suspension: 300 mg/5 mL

For More Information:
www.us.sandoz.com


Pramipexole Dihydrochloride Tablets

Marketed by:
Teva Pharmaceuticals (North Wales, PA)

Compared to:
Mirapex (Boehringer Ingelheim)

Indication:
Teva Pharmaceuticals recently announced the availability and introduction of Pramipexole Dihydrochloride Tablets. The product is AB-rated and is bioequivalent to Mirapex Tablets. Pramipexole Dihydrochloride Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease. Pramipexole is a nonergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 subfamily of dopamine receptors, binding with higher affinity to D3 than D2 or D4 receptor subtypes. Pramipexole Dihydrochloride Tablets are available in a 0.125-mg strength, in a bottle size of 63, and in 0.25-, 0.5-, 1-, and 1.5-mg strengths, in bottle sizes of 90.

Dosage Form:
Tablets: 0.125, 0.25, 0.5, 1, 1.5 mg

For More Information:
www.tevausa.com
888-TEVA USA or (888-838-2872)


PANCRELIPASE Delayed-release Capsules

Marketed by:
X-GEN Pharmaceuticals Inc (Big Flats, NY)

Compared to:
Zenpep (pancrelipase) delayed-release capsules

Indication:

X-GEN Specialty Division announced that it entered into a distribution agreement with Eurand Pharmaceuticals Inc for an authorized generic to the company’s FDA-approved pancreatic enzyme product ZENPEP (pancrelipase) delayed-release capsules, a product developed to meet the 2004 pancreatic enzyme product guidelines and regulations, approved by the FDA in August 2009. In accordance with the agreement, X-GEN will distribute PANCRELIPASE (pancrelipase) delayed-release capsules, the authorized generic to the low-dosage strength of ZENPEP. PANCRELIPASE capsules are orally administered and contain delayed-release beads of porcine pancreatic enzyme concentrate.

Dosage Form:
PANCRELIPASE capsules are orally administered and contain delayed-release beads of porcine pancreatic enzyme concentrate consisting of lipase (5,000 USP units), amylase (27,000 USP units) and protease (17,000 USP units).

For More Information:
www.x-gen.us
607-562-2700


Tramadol/APAP Tablets

Marketed by:
Amneal Pharmaceuticals (Hauppage, NY)

Compared to:
Ultracet (Ortho-McNeil Janssen)

Indication:
Amneal Pharmaceuticals announced that it received FDA approval to manufacture combination Tramadol HCl in 37.5-mg strength and acetaminophen in 325-mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet. Tramadol/APAP is a centrally acting analgesic indicated for the short-term management of moderately severe acute pain. The product is designated a controlled substance in some states.

Dosage Form:
Tablets: 37.5 mg Tramadol HCl, 325 mg acetaminophen

For More Information:
www.amneal.com ■


Generic News

FDA Approval Process Longer for Generics

Health care professionals and patients are facing a longer wait for the FDA to approve generic drugs than just 5 years ago—1 year longer, in fact. The delayed approval process is due to a growing backlog of applications at the FDA.

At the recent annual meeting of the Generic Pharmaceutical Association, FDA commissioner Margaret A. Hamburg, MD, announced her intent to fix the problem—“It’s a real problem. I don’t pretend to believe that the status quo is acceptable.” She noted that charging application fees to the companies seeking approval for generic drug could speed up the process and alleviate the generic drugs department’s deficiency in funds.

In 2005, the average time to approval for generic drugs by the FDA was 16.3 months from the filing of the application. Last year, that wait time increased to 26.7 months, due to limited staff to review an increasing number of applications. The FDA has been so overwhelmed, in fact, by the increasing number of applications, that the backlog of pending generic applications is now at 2000—more than double the amount of pending applications in 2005. Gary J. Buehler, director of the FDA’s office of generic drugs, said that, beginning in 2003, the agency has received nearly 800 applications a year, up from an average of 330 applications a year in the last decade.

Generic drug makers state that the underfunding of the FDA’s generics office is preventing patients from obtaining more affordable medicines. The fiscal year 2010 budget for the office of generic drugs is $51 million, which is up $10 million from fiscal year 2009. Last year, generics accounted for 70.4% of the 2.9 billion prescriptions in the United States, according to IMS Health. Generic prescriptions accounted for only 15% of the $300 billion spent on prescription drugs.

The delayed approval process hurts patients and government payers like Medicare—prices stay higher when no or just a few generic products exist. The generic industry supports a user-fee program—as long as it is modeled after the program that is already in place for brand name drugs—in which fees are associated with timely review and action on applications.

Buehler stated that the FDA is looking for ways to streamline the process, with an intent to eliminate the application backlog by 2012. ■