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Drugs in the News,
 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.
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(1), 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(2). ADHD is thought to affect about eight million, or one in 20, adults in the United States(3), and research on the life span of the condition notes the disorder impairs academic, social and occupational functioning(1), and is associated with academic underachievement, conduct problems, underemployment, motor vehicle safety and difficulties with personal relationships(1).
FDA Lifts Clinical Hold on Genta's Tesetaxel, a Leading Oral Taxane
Genta Incorporated (BULLETIN BOARD: GNTA) announced that the Company has received notification from the U.S. Food and Drug Administration (FDA) that Genta may resume clinical trials with tesetaxel, a leading oral taxane in Genta's oncology product portfolio. The notification was made in response to the Company's submission of a complete response to a prior notice from FDA that had placed the drug on "clinical hold".
U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel(R)
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed Pentacel(R), Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine. Pentacel(R) vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b (Hib). Pentacel(R) vaccine is approved for use in infants and children 6 weeks through 4 years of age (prior to fifth birthday).
Sirion Therapeutics Announces FDA Approval of Durezol(TM) for Treatment of Postoperative Ocular Inflammation and Pain.
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM) (difluprednate ophthalmic emulsion) 0.05%, a topical steroid for the treatment of postoperative ocular inflammation and pain. The approval came after a six month priority review.
U.S. FDA Licenses Pentacel(R) Vaccine For Use in Young Children
The U.S. Food and Drug Administration (FDA) has licensed Pentacel(R) vaccine, a combination vaccine for use as a four-dose series at 2, 4, 6, and 15-18 months of age.
Pentacel vaccine protects against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b (Hib). According to the current Recommended Childhood Immunization Schedule of the U.S. Centers for Disease Control and Prevention (CDC), up to 23 injections are needed by the time an infant has reached 18 months of age. The use of Pentacel vaccine could reduce that number of shots by seven when compared to immunization with single-entity vaccines.
New Aptivus(R) (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted approval of Aptivus(R) (tipranavir) capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2-18 infected with HIV-1. The oral solution formulation, which is a new dosage form of APTIVUS, was also approved for treatment-experienced adults. The oral solution formulation will be available in the U.S. beginning in mid-September. The FDA granted full (traditional) approval to APTIVUS capsules for treatment-experienced adults in October 2007.
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