Lupin Receives USFDA Approval for Topiramate Tablets
BALTIMORE, May 30 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI)
announced today that it has received tentative approval for the Company's
Abbreviated New Drug Application (ANDA) for Topiramate
tablets, 25 mg, 50
mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA).
Mylan Announces Tentative FDA Approval for Topiramate Capsules
PITTSBURGH, Sept. 10 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc.
(NYSE: MYL ) today announced that Mylan Pharmaceuticals Inc. has received
tentative approval from the U.S. Food and Drug Administration (FDA) for its
Abbreviated New Drug Application (ANDA) for Topiramate
Capsules, 15 mg a...
Early stimulus funding supports research in adolescent addiction
...ican Recovery and Reinvestment Act of 2009. The study will look at the drug topiramate
to see if it helps reduce marijuana addiction among high-school students. topiramate
has been shown previously to help reduce alcohol use.
Funding for Mirand...
VIVUS' Qnexa Shows Significantly Improved Blood Sugar Control Through Weight Loss In Patients With Type 2 Diabetes
...ts with type 2 diabetes.
Qnexa (Q-NEX-uh) is a proprietary, low dose, controlled release formulation of phentermine and topiramate
that simultaneously addresses both appetite and satiety -- the two main mechanisms that impact eating behavior -- in one daily capsule. Qnexa, an inve...
Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Topamax(R) Tablets
...aboratories, Ltd. (NYSE AMEX: CPD ) has launched topiramate
tablets on behalf of Sun Pharmaceutical Industries...cation (ANDA) for generic Topamax(R) tablets.
tablets are used as initial monotherapy in patient...res, or primary generalized tonic-clonic seizures. topiramate
tablets are indicated as adjunctive therapy for ad...
Zydus Pharmaceuticals (USA) Inc. Announces FDA Final Approval for the Generic Version of Topamax(R) Tablets
...or its Abbreviated New Drug Application (ANDA) for topiramate
Tablets USP, 25mg, 50mg, 100mg, and 200mg. This product is available for immediate shipment.
tablets are indicated as an initial monotherapy in...seizures associated with Lennox-Gastaut syndrome. topiramate
tablets are the generic version of Ortho-McNeil-Ja...
FDA Adds Suicide Warning to Epilepsy Drugs
...e strongest "black box" warning on this class of drugs, which includes widely used medications such as clonazepam (Klonopin), phenytoin (Dilantin) and topiramate
"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, su...
Epilepsy Drug May Raise Autism Risk in Offspring
Drugs for this condition have encountered other problems. Previous studies have also found that pregnant women who use the epilepsy drug topiramate
(brand name Topamax) alone or in combination with other epilepsy drugs may be increasing their risk of birth defects. And the U.S. Food and Drug Admin...
Diet may eliminate spasms for infants with epilepsy
...t worked in 8-of-13 infants within approximately one week. Only 1-of-8 had recurring spasms, and that infant was controlled again with the addition of topiramate
to the diet. Side effects were fewer than ACTH in this series and the recurrence rate was also lower with the diet. In the 5 patients in which the die...
Epilepsy Drug May Boost Birth Defect Risk
... Women who take topiramate
should discuss preconception planning with their d... News) -- Pregnant women who use the epilepsy drug topiramate
alone or in combination with other epilepsy drugs ... of birth defects, British researchers report.
(brand name Topamax) is a common anti-seizure medi...
Spherics, Inc. Announces Reduced Cognitive Impairment of Novel Extended Release Topiramate (SRx-502) as Compared to Topamax(R)
Findings Presented At The American Society Of Clinical Psychopharmacology Meeting
WELLESLEY HILLS, Mass., Sept. 15 /PRNewswire/ -- Joseph F. Finn, Jr.,
C.P.A. ("Finn"), Assignee of the assets of Spherics, Inc. ("Spherics") for
the benefit of creditors, announced t...
Results From Phase 3 EQUATE Trial of VIVUS' Qnexa Highlighted at European Congress on Obesity
...ment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramate
CR), full-dose Qnexa (15 mg phentermine/92 mg topiramate
CR), the respective phentermine and controlled-release topiramate
constituents, or placebo. Patients had a four-week...
VIVUS Announces Abstract Published at American Diabetes Association
... Scientist. VIVUS
is currently developing Qnexa, which is a proprietary
pharmaceutical treatment that is a combination of low doses of
phentermine and topiramate
that is being investigated for the
treatment of obesity. The abstract discussed by Dr. Najarian and
published in the American Diabetes Association 200...
Multiple Vimpat(R) (lacosamide) Studies Presented at American Epilepsy Society Annual Meeting
(29.0 percent), valproate (23.6 percent), and topiramate
(22.3 percent). At
baseline, patients reported mor...- Valproate (45.3 percent vs. 21.3 percent)
(41.4 percent vs. 28.5 percent)
-- Oxcarbazepi...- Valproate (47.5 percent vs. 26.9 percent)
(41.9 percent vs. 25.6 percent)
Spherics, Inc. Presented Three Key Technologies (BIOROD(TM), BIOGIT(TM), and SPHEROMER(TM)) at the 35th Annual Meeting of Controlled Release Society
...ioadhesion Performance of
3. Pharmacokinetics Evaluation of topiramate
Immediate Release Tablets
Extended Release Capsules in Healthy Volunteers (BIOGIT
Spherics, Inc. Successful Bidder May Make MHRA Submission
...property will be sold at a sealed bid auction on October 10,
One of the pieces of intellectual property for sale is its lead
product, SRx-502, topiramate
Extended Release, a once-a-day version of a
branded drug that currently has more than $2 billion in U.S. sales despite
twice daily dosing and an unfav...