New Drug Application News and Research

RSS

NDA for Lubiprostone to treat irritable bowel syndrome with constipation

Sucampo Pharmaceuticals, Inc., has announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).

13 Jul 2007

Barr confirms patent challenge of Aggrenox

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Boehringer Ingelheim in connection with its Aggrenox Aspirin/Extended- Release Dipyridamole) 25 mg/200 mg capsules.

13 Jul 2007

Caraco Pharmaceutical Labs announces FDA approval to market generic Tenormin

Caraco Pharmaceutical Laboratories has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Atenolol Tablets USP (atenolol).

12 Jul 2007

Roxane Laboratories announces launch of Amlodipine Besylate tablets

Roxane Laboratories, Inc. has announced the approval of its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg by the U.S. Food and Drug Administration.

10 Jul 2007

Pharmaxis files for Korean marketing approval of its lung function test Aridol

Pharmaxis has announced its first step into the Asian market, filing for Korean marketing approval of its lung function test Aridol.

10 Jul 2007

Approval of generic Dostinex

Barr Pharmaceuticals, Inc. has announced that its subsidiary Barr Laboratories, Inc. has received final U.S. Food & Drug Administration (FDA) approval for its application to manufacture and market a generic version of Pharmacia and Upjohn Company's Dostinex (cabergoline) tablets, 0.5 mg.

10 Jul 2007

Bayer and Onyx submit supplemental NDA for Nexavar

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced that a Supplemental New Drug Application (sNDA) for Nexavar (sorafenib) tablets has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer.

28 Jun 2007

Barr announces tentative approval for generic version of Effexor tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary PLIVA has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Wyeth Pharmaceuticals Inc.'s Effexor (Venlafaxine Hydrochloride) Tablets, 25mg, 37.5mg, 50mg, 75mg and 100mg.

27 Jun 2007

Bristol-Myers Squibb granted NDA for ixabepilone

Bristol-Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the New Drug Application (NDA) for the investigational compound ixabepilone, an epothilone B analog.

20 Jun 2007

Orphan drug status granted to Immtech for malaria treatment pafuramidine

Immtech Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for pafuramidine (DB289) for the treatment of malaria.

19 Jun 2007

Genzyme announces results of clinical trials of Renvela and Renagel

Genzyme Corp. has announced the results of two new studies comparing a powder form of Renvela (sevelamer carbonate) to Renagel tablets (sevelamer hydrochloride), including one trial in which patients received the powder form three times per day, and one in which it was administered once per day.

19 Jun 2007

Lupin announces FDA approval of Trandolapril tablets

Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1mg, 2mg and 4mg. Commercial shipments of Trandolapril tablets have commenced.

17 Jun 2007

Solvay Pharmaceuticals submits supplemental NDA for AndroGel

Solvay Pharmaceuticals, Inc., has announced that it submitted a supplemental New Drug Application (sNDA) for AndroGel (testosterone gel) 1% CIII to the U.S. Food and Drug Administration (FDA) for treatment in male adolescents ages 13-17 years old with primary or secondary hypogonadism.

17 Jun 2007

Neurocrine Biosciences announces resubmission of NDA for Indiplon capsules

Neurocrine Biosciences, Inc. has announced that they have resubmitted its New Drug Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of insomnia in both adult and elderly patients to the U.S. Food and Drug Administration (FDA).

14 Jun 2007

Priority review granted for oral formulation of HYCAMTIN (topotecan)

GlaxoSmithKline (GSK) has announced that its new drug application (NDA) for ORAL HYCAMTIN (topotecan) capsules, a treatment for relapsed small cell lung cancer (SCLC), has been granted Priority Review by the United States Food and Drug Administration (FDA).

14 Jun 2007

Eurand files NDA for Zentase for the treatment of exocrine pancreatic insufficiency

Eurand has announced that Eurand Pharmaceuticals Ltd. initiated the rolling submission of its new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for Zentase for the treatment of Exocrine Pancreatic Insufficiency (EPI). Zentase (formerly EUR-1008), the company's lead product candidate, has been granted fast-track designation by the FDA.

14 Jun 2007

Clinical study results on bifeprunox for schizophrenia

Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals and Lundbeck A/S presented clinical study results on bifeprunox, an investigational treatment for adult patients diagnosed with schizophrenia, at the 2007 annual meeting of the American Psychiatric Association.

24 May 2007

Lupin receives FDA approval for Ziprasidone Hydrochloride capsules

Lupin Pharmaceuticals has announced that on May 16, 2007 it received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Ziprasidone Hydrochloride Capsules 20mg, 40mg, 60mg and 80mg.

24 May 2007

FDA approves VELCADE plus DOXIL combination for multiple myeloma

Ortho Biotech Products has announced the U.S. Food and Drug Administration (FDA) has approved the use of DOXIL (doxorubicin HCl liposome injection) in combination with VELCADE (bortezomib) for Injection to treat patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy.

23 May 2007

Lubiprostone may improve symptom relief rates in adults with irritable bowel syndrome with constipation

A new study demonstrated that the active ingredient in AMITIZA (lubiprostone), given 8 mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation (IBS-C).

22 May 2007