New Drug Application News and Research

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AstraZeneca submits sNDA for SEROQUEL XR for treatment of major depressive disorder

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of major depressive disorder (MDD) as monotherapy, adjunct therapy, and maintenance therapy in adult patients.

1 Mar 2008

Abilify (aripiprazole) approved for acute treatment of bipolar I disorder in adolescents

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for ABILIFY (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients (10 to 17 years old).

1 Mar 2008

Barr confirms Avodart patent challenge

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (dutasteride) soft gelatin capsules, 0.5mg.

27 Feb 2008

FDA approves XYZAL (levocetirizine dihydrochloride) for allergies and chronic idiopathic urticaria

UCB and sanofi-aventis have announced that the U.S. Food and Drug Administration (FDA) approved a New Drug Application (NDA) for XYZAL (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, a prescription antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies, as well as the treatment of chronic idiopathic urticaria.

20 Feb 2008

Barr receives approval for generic Mirapex tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex Tablets (Pramipexole Dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

20 Feb 2008

FDA extends review of Genasense NDA appeal in chronic lymphocytic leukemia

Genta Incorporated has announced that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasense (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

15 Jan 2008

Caraco Pharmaceutical Labs announces FDA approval to market generic Metaglip

Caraco Pharmaceutical Laboratories, Ltd., has announced that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Glipizide/Metformin Hydrochloride Tablets, 2.5/250 mg, 2.5/500 mg and 5/500 mg (Glipizide/Metformin HCl).

15 Jan 2008

Barr Pharmaceuticals confirms patent challenge of Namenda tablets

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Forest Laboratories, Inc. in connection with its Namenda (memantine hydrochloride) tablets, 5mg and 10mg.

14 Jan 2008

Barr Pharmaceuticals confirms Eloxatin injectable patent challenge

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, has initiated a challenge of the patents listed by Sanofi-Aventis U.S. LLC in connection with its Eloxatin(R) (Oxaliplatin Aqueous Solution), 5mg/mL Injectable.

10 Jan 2008

Takeda submits NDA for Alogliptin (SYR-322) in the U.S.

Takeda Pharmaceutical Company Limited (Takeda) has announced that Takeda Global Research & Development Center, Inc. submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for alogliptin (development code: SYR-322), a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor under investigation for the treatment of type 2 diabetes.

7 Jan 2008

Daiichi Sankyo, Lilly submit NDA for investigational antiplatelet drug, Prasugrelin U.S.

Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA).

7 Jan 2008

Watson Pharmaceuticals launches generic Biaxin

Watson Pharmaceuticals, Inc. has announced it has launched Clarithromycin Extended-Release Tablets, USP in the 500 mg strength.

4 Jan 2008

Watson receives FDA approval for generic DuoNeb

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.).

3 Jan 2008

Perrigo receives FDA OK for OTC Cetirizine Hydrochloride tablets

Perrigo Company has announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.

2 Jan 2008

Mylan announces FDA approval for Cetirizine Hydrochloride tablets

Mylan Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.

2 Jan 2008

Barr sues Watson and Sandoz for Seasonale patent infringement

Barr Pharmaceuticals, Inc. (NYSE:BRL) today announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, Inc. has filed suits against Watson Pharmaceuticals (NYSE:WPI) and against Sandoz, a subsidiary of Novartis (NYSE:NVS) for infringement of the patent protecting Duramed's SEASONALE(R) extended-cycle oral contraceptive product.

17 Dec 2007

New drug candidate knocks out resistant form of chronic myeloid leukemia

Oregon Health & Science University Cancer Institute researchers have found a new, experimental drug candidate it to be effective against a highly resistant mutation in chronic myeloid leukemia (CML).

10 Dec 2007

Resverlogix receives FDA approval to start clinical trial for RVX-208

Resverlogix Corp. has announced that it has received approval by the US Food and Drug Administration (FDA) to initiate a Phase 1a clinical trial of oral RVX-208 in the USA. RVX-208 is a novel first-in-class small molecule that increases the production of ApoA-I and HDL.

10 Dec 2007

FDA to review potential anti-arrhythmic claims for Ranexa

CV Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will evaluate the approval of potential anti-arrhythmic claims for Ranexa (ranolazine extended-release tablets) as part of its ongoing review of the Company's supplemental new drug application (sNDA).

10 Dec 2007

Caraco Pharmaceutical Labs announces FDA approval to market generic Norvasc

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 Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine).

5 Dec 2007