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Drugs in the News,
 PEAK Surgical Receives 510(k) Clearance to Market PEAK(R) Surgery System for Use in General Surgery
PEAK Surgical, Inc., a medical device company that has developed a new tissue dissection system based on a proprietary technology, today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its PEAK(R) Surgery System for use in general surgery. The PEAK Surgery System combines the PULSAR(TM) Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBlade(TM) 4.0, a low-temperature surgical cutting and coagulation tool. This tissue dissection system will be commercially available next month.
Barr Confirms Patent Challenge of Fentora(R) Tablets
Barr Pharmaceuticals, Inc. (NYSE:BRL)
today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a
challenge of the patents listed by Cephalon, Inc. in connection with its
Fentora(R) Tablets (fentanyl citrate buccal tablets), equivalent to fentanyl
base 100 mcg, 400 mcg, 600 mcg and 800 mcg. For more information, visit
www.barrlabs.com.
FDA Grants Pediatric Exclusivity for TOPAMAX(R)
Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals,
Inc., announced today that the U.S. Food and Drug Administration (FDA) has
granted pediatric exclusivity for TOPAMAX(R) (topiramate), based on studies
submitted in response to a Written Request by the FDA to investigate the use of
TOPAMAX in pediatric patients aged 1 to 24 months with partial onset seizures.
More information can be found at
http://www.jnjpharmarnd.com/.
FDA Approves RITUXAN
RITUXAN, the first and only CD-20 positive B-Cell targeted biologic for
Rheumatoid Arthritis, is FDA approved in combination with Methotrexate to slow
the progression of structural damage in adult paitnets with moderately to
severely active RA who have had an inadequate rsponse to one or more tumor
necorsis factor inhibitors. RITUXAN is part of a class of drugs called biologis,
which are showing great promise in treating disease like RA. For full
prescribing information, visit
RITUXAN.COM
SyntheMed Receives Canadian Approval for REPEL-CV(R)
SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion, drug delivery products and other surgical implants, announced today that REPEL-CV(R), the company's bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery, has received Health Canada approval for use in pediatric patients who undergo open heart surgery. REPEL-CV will be marketed throughout Canada by Force3 Medicale, Inc., a Montreal-based distributor of cardiac surgery products.
FDA Accepts Genta's NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
Genta Incorporated (BULLETIN BOARD: GNTA) announced that the Food and Drug
Administration
(FDA) has
accepted the
Company's
amendment to its
New Drug
Application
(NDA) for
Genasense(R) (oblimersen
sodium)
Injection as a
"complete
response". The
NDA proposed the
use of Genasense
plus
chemotherapy for
patients with
relapsed or
refractory
chronic
lymphocytic
leukemia (CLL).
The recent
submission was
based on new
information from
the Company's
completed,
randomized Phase
3 trial that
showed, among
other findings,
a significant
increase in
overall survival
for patients who
achieved a
complete or
partial response
when treated
with Genasense
plus
chemotherapy
compared with
patients treated
with
chemotherapy
alone. For more
information
about Genta,
please visit
www.genta.com.
FDA Updates Label for AVANDIA(R) to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years
GlaxoSmithKline (NYSE:
GSK) announces today that the U.S. Food and Drug Administration (FDA)
updated the prescribing information for AVANDIA(R) (rosiglitazone maleate) to
include clinical findings from A Diabetes Outcome Progression Trial (ADOPT), a
4- to- 6 year head-to-head study of AVANDIA versus metformin and glyburide
monotherapy in recently diagnosed type 2 diabetes patients. The percentage of
patients with inadequate glucose control at five years was 34 percent with
glyburide, 21 percent with metformin and only 15 percent with AVANDIA. The
difference between AVANDIA and the comparators was statistically significant.
Watson Launches Generic MARINOL(R) Capsules
Watson Pharmaceuticals, Inc. (NYSE:WPI), a leading specialty pharmaceutical company, announced today that, under a supply agreement with Solvay Pharmaceuticals, Inc., Watson has launched the authorized generic version of dronabinol in the 2.5, 5 and 10 mg once daily dosage strengths. Dronabinol is the generic version of Solvay Pharmaceuticals' MARINOL(R) (dronabinol) CIII Capsules, indicated to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol is also indicated to treat anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS). For the 12-months ending December 2007, Solvay reported MARINOL(R) sales of 105 million.
Indevus Receives Approvable Letter from FDA for NEBIDO(R)
Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV) today announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for NEBIDO(R) related to a New Drug Application (NDA) submitted to the FDA in August 2007. The letter, received on June 27, 2008, indicated that the application may be approved if the Company is able to adequately respond to certain clinical deficiencies related to the product.
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Elavil(R)
Caraco Pharmaceutical Laboratories, Ltd., (AMEX:CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Applications (ANDAs) for Amitriptyline Hydrochloride USP Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
Amitriptyline Hydrochloride is an antidepressant. Its use is indicated to treat symptoms of depression. According to IMS Data, for the twelve months ended March, 2008, Amitriptyline Hydrochloride USP Tablets had annual generic sales of approximately $16 million. It is marketed under the brand name of Elavil(R), a registered trademark of AstraZeneca.
FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents
Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.
Janssen Announces Launch of Authorized Generic for RISPERDAL(R)
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced that it has launched an authorized generic version of RISPERDAL(R) (risperidone) through Patriot Pharmaceuticals, L.L.C.
Patriot is a subsidiary of McNeil-PPC. Both companies are a part of the Johnson & Johnson family of companies.
Janssen also announced that it will continue to make available branded RISPERDAL, which was first approved by the FDA in 1993.
RISPERDAL (risperidone) is indicated for the treatment of schizophrenia in adults and adolescents aged 13-17 years; and the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years.
FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
ADHD is the most common emotional, cognitive and behavioral disorder treated in children, and according to the National Institute of Mental Health (NIMH), between 30 percent and 70 percent of children with ADHD continue to exhibit symptoms in the adult years. ADHD is thought to affect about eight million, or one in 20, adults in the United States, and research on the life span of the condition notes the disorder impairs academic, social and occupational functioning, and is associated with academic underachievement, conduct problems, underemployment, motor vehicle safety and difficulties with personal relationships.
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