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FDA authorizes INDA for recombinant human C1 inhibitor in kidney transplantation

Biotech company Pharming Group NV has announced that the US Food and Drug Administration (FDA) has authorized a clinical study with recombinant human C1 inhibitor (rhC1INH) for the treatment of antibody-mediated rejection (AMR) in kidney transplantation. Dr. Hans Sollinger of the University of Wisconsin, Madison will conduct the clinical trial with rhC1INH under an Investigator IND from the FDA.

3 Sep 2008

Spinifex secures major investment to develop pain drug

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured venture capital investment of A$12 million from GBS Venture Partners Limited, Brandon Capital Partners and Uniseed to fund the development of its pain management drug, EMA401.

2 Sep 2008

Mylan's Alphapharm victorious in Razadyne patent challenge

Mylan Inc. has announced that its subsidiary Alphapharm Pty Limited won a favorable decision in patent litigation against it and Barr Laboratories Inc. relating to Galantamine Tablets, USP, the generic version of Ortho-McNeil's Razadyne Tablets, 4 mg, 8 mg and 12 mg.

31 Aug 2008

Barr receives U.S. approval for generic Razadyne tablets

Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., received final approval from the U.S. Food & Drug Administration (FDA) to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne (galantamine hydrobromide), 4 mg, 8 mg and 12 mg tablets. Barr intends to launch its generic Razadyne tablets product immediately.

28 Aug 2008

FDA grants IND for Davanat to treat breast cancer patient

Pro-Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) application for use of Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Kentucky. Davanat also is being administered in Phase II clinical trials for first-line treatment of colorectal and biliary cancer patients.

28 Aug 2008

VioQuest Pharmaceuticals issued new U.S. patent for Lenocta

VioQuest Pharmaceuticals today announced that the United States Patent and Trademark Office has issued the first patent for the company's investigational product candidate Lenocta (sodium stibogluconate). U.S. Patent No. 7,416,723 entitled "Therapeutic compositions and methods useful in modulating protein tyrosine phosphatases," encompasses novel compositions including Lenocta for the treatment of cancer and a broad range of other diseases.

26 Aug 2008

OncoGenex Pharmaceuticals' OGX-011 granted FDA fast track status

OncoGenex Pharmaceuticals has announced that OGX-011, also known as custirsen sodium, received Fast Track designation from the U.S. Food & Drug Administration (FDA) in combination with docetaxel for progressive metastatic prostate cancer.

24 Aug 2008

Watson announces ruling in Naproxen sodium patent case

Watson Pharmaceuticals, Inc. announced today that the United States District Court for the Southern District of Florida ruled today that Watson's Naproxen Sodium ER tablets, the generic version of Naprelan, infringes Elan's U.S. Patent No. 5,637,320 (the "'320 Patent").

13 Aug 2008

IMPAX sued for patent infringement on generic Ultram ER

IMPAX Laboratories, Inc. today announced Purdue Pharma Products L.P. ("Purdue"), Napp Pharmaceutical Group Ltd. ("Napp"), Biovail Laboratories International, SRL ("Biovail") and Ortho-McNeil, Inc. ("Ortho-McNeil") have filed suit for patent infringement in the United States District Court for the District of Delaware based on the Company's submission of its Abbreviated New Drug Application ("ANDA") for tramadol hydrochloride extended-release tablets (100 mg), generic of Ultram ER, to the Food and Drug Administration.

12 Aug 2008

Barr confirms Xyzal tablet patent challenge

Barr Pharmaceuticals, Inc. has confirmed that its subsidiaries, Barr Laboratories, Inc. and PLIVA-Hrvatska D.O.O., have initiated a challenge of the patent listed by UCB Inc. in connection with its Xyzal(R) Tablets (levocetirizine dihydrochloride), 5mg.

31 Jul 2008

Barr confirms patent challenge of Sensipar tablets

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Amgen Inc. in connection with its Sensipar Tablets (cincalcet hydrochloride), 30mg, 60mg and 90mg.

29 Jul 2008

Barr confirms Fentora tablet patent challenge

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Cephalon, Inc. in connection with its Fentora(R) Tablets (fentanyl citrate buccal tablets), equivalent to fentanyl base 100 mcg, 400 mcg, 600 mcg and 800 mcg.

24 Jul 2008

U.S. authorities seize Xiadafil VIP tablets after company refuses to recall product

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

24 Jul 2008

Samaritan Pharmaceuticals granted IND from FDA for HIV drug

Samaritan Pharmaceuticals has announced that it has filed an IND (Investigational New Drug) application for SP-6310 in the treatment of HIV-infected patients with abnormal cortisol levels.

8 Jul 2008

Barr announces favorable ruling in Mirapex patent challenge

Barr Pharmaceuticals, Inc. has announced that U.S. District Court for Delaware has ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Boehringer Ingelheim Pharmaceuticals, Inc. in connection with Boehringer Ingelheim's Mirapex(R) Tablets (pramipexole dihydrochloride) 0.125mg, 0.25mg, 0.5mg, 1mg & 1.5mg.

26 Jun 2008

Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

16 Jun 2008

Barr confirms patent challenge of Prevacid SoluTab tablets

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets (lansoprazole), 15mg and 30mg.

11 Jun 2008

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Mylan Inc. has announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.

9 Jun 2008

FDA grants pediatric exclusivity for UCB's Keppra

UCB has announced that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001.

8 Jun 2008

Mylan confirms Azor patent challenge

Mylan Inc. today confirmed that its majority-owned subsidiary, Matrix Laboratories Ltd., has been sued by Daiichi Sankyo in connection with Amlodipine Besylate/Olmesartan Medoxomil Tablets, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg, the generic version of Daiichi Sankyo's Azor Tablets.

4 Jun 2008