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Cephalon files patent infringement case against Watson Pharmaceuticals

Cephalon, Inc. today announced that it and its wholly-owned subsidiary CIMA LABS INC. have filed a lawsuit in U.S. District Court in Delaware against Watson Pharmaceuticals, Inc. and its wholly-owned subsidiary, Watson Laboratories, Inc., for infringement of U.S. Patent Nos. 6,200,604 and 6,974,590, which cover methods of use for the Cephalon product FENTORA(R) (fentanyl buccal tablet) [C-II].

3 Jun 2008

Watson receives approval of Omeprazole delayed-release capsules

Watson Pharmaceuticals, Inc. has announced today that it has received final approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Capsules USP in the 10mg, 20mg and 40mg strengths.

2 Jun 2008

Barr confirms Entocort patent challenge

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by AstraZeneca LP in connection with its Entocort(R) Enteric Coated Capsules (budesonide), 3mg.

27 May 2008

Advaxis files investigational new drug application for Lovaxin C

Advaxis Inc. completed its filing of a new investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA"). This filing follows the successful completion of a Phase I study overseas.

20 May 2008

Lubiprostone brings relief for many IBS patients who experience constipation

Many patients may soon find relief from the bloating, cramping, abdominal pain and constipation associated with irritable bowel syndrome, or IBS.

19 May 2008

Starpharma reports positive VivaGel clinical study results

Starpharma Holdings Limited today announced positive results of a clinical trial that achieved all its objectives demonstrating that 3% SPL7013 Gel (VivaGel) was safe and well-tolerated in sexually abstinent women when administered vaginally, twice daily for 14 days.

11 May 2008

Barr announces approval of generic version of Yasmin (drospirenone and ethinyl estradiol)

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 Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.

9 May 2008

Patent claims allowed covering Samaritan's Alzheimer's memory recovery drug in Australia

Samaritan Pharmaceuticals, a biopharmaceutical company committed to commercializing new innovative therapeutic drugs, has received notification that the claims in the patent application for "Neuroprotective Spirostenol Pharmaceutical Compositions" covering Caprospinol (SP-233) have been allowed by the Australian Patent Office.

6 May 2008

Drug candidate to treat smallpox scaled up by new partnership

Two American companies are teaming up for second-round test-phase production of a FDA-designated "fast track" drug candidate to treat smallpox, a deadly virus that is feared to be able to reach people through acts of bio-warfare or bio-terrorism.

5 May 2008

AstraZeneca submits sNDA for SYMBICORT in chronic obstructive pulmonary disease

AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.

30 Apr 2008

ISTA Pharmaceuticals announces new clinical findings to support Bepreve NDA

ISTA Pharmaceuticals, Inc. has announced positive results from the preliminary analysis of its second and final Bepreve (bepotastine ophthalmic solution) Phase III clinical study.

30 Apr 2008

Taro Pharmaceutical receives final FDA approval for Cetirizine Hydrochloride oral solution

Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for cetirizine hydrochloride oral solution, 1 mg / 1 mL ("Cetirizine Oral Solution").

22 Apr 2008

Orphan Europe files NDA with FDA for Carbaglu (carglumic acid)

Recordati announced the submission to the U.S. FDA by Orphan Europe (a Recordati group company) of an Original New Drug Application (NDA) for Carbaglu (carglumic acid).

21 Apr 2008

NicOx signs agreement for commercial manufacture of Naproxcinod drug substance

NicOx S.A. (Euronext Paris: COX) has announced it has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of naproxcinod drug substance (or active pharmaceutical ingredient, API).

20 Mar 2008

FDA sends approvable letter for Ceftobiprole as treatment of complicated skin infections

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), has announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

19 Mar 2008

Watson Pharmaceuticals files application for generic LYBREL

Watson Pharmaceuticals, Inc. has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its Levonorgestrel and Ethinyl Estradiol tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth.

14 Mar 2008

Watson Pharmaceuticals files application for generic SEASONIQUE

Watson Pharmaceuticals, Inc. has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc.

6 Mar 2008

FDA approves Aloxi injection for prevention of postoperative nausea and vomiting

Eisai Corporation of North America, its U.S. subsidiary, MGI PHARMA, INC., and Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved Aloxi (palonosetron hydrochloride) injection for the prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

4 Mar 2008

Barr Pharmaceuticals announces favorable ruling in Yasmin patent case

Barr Pharmaceuticals, Inc. has announced that the U.S. District Court for the District of New Jersey has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG in connection with Bayer Schering's Yasmin(R) (drospirenone and ethinyl estradiol) oral contraceptive.

4 Mar 2008

FDA grants priority review for ACIPHEX (rabeprazole sodium) sNDA for treatment of GERD in adolescents

Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., has announced that the Food and Drug Administration (FDA) has accepted an ACIPHEX supplemental New Drug Application (sNDA) for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in patients ages 12-16.

3 Mar 2008