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NicOx signs agreement with DSM for the commercial manufacture of naproxcinod drug substance

NicOx S.A. has announced it has signed an agreement with DSM for the commercial manufacture and supply of naproxcinod drug substance (or API, active pharmaceutical ingredient).

3 Dec 2008

Mylan confirms first-to-file patent challenge of AMRIX capsules

Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Cephalon Inc., Eurand Inc. and Anesta AG in connection with the filing of an Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX Capsules.

1 Dec 2008

New cream for vaginal dryness approved

Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for Synthetic Conjugated Estrogens-A (SCE-A) 0.625 mg/g Vaginal Cream.

1 Dec 2008

Anadys Pharmaceuticals receives fast track for ANA598 treatment of chronic hepatitis C virus

Anadys Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to ANA598 for the treatment of chronic hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C non-nucleoside polymerase inhibitor.

1 Dec 2008

Eli Lilly withdraws application for additional U.S. indication for Cymbalta for chronic pain

Eli Lilly and Company has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta (duloxetine HCl) for the management of chronic pain.

30 Nov 2008

Watson Pharmaceuticals receives FDA approval for generic Wellbutrin XL

Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc., has received final approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL) in the 150 mg strength.

26 Nov 2008

FDA issues complete response letter for Ceftobiprole for treatment of complicated skin infections

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received a Complete Response 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.

26 Nov 2008

Barr Labs confirms patent challenge of Amrix extended-release capsules

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Anesta in connection with its Amrix (cyclobenzaprine hydrochloride) extended-release capsules, 15mg and 30mg.

26 Nov 2008

AstraZeneca settles U.S. Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals

AstraZeneca has announced it has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA.

25 Nov 2008

Febuxostat recommended by panel for treatment of hyperuricemia in patients with gout

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout.

25 Nov 2008

FDA accepts Labopharm's NDA for formulation of trazodone

Labopharm Inc. has announced that its New Drug Application (NDA) for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA).

24 Nov 2008

King Pharmaceuticals and Alpharma sign definitive merger agreement

King Pharmaceuticals, Inc. and Alpharma Inc. have announced that the two companies have signed a definitive merger agreement under which King will acquire all of the outstanding shares of Class A Common Stock of Alpharma for $37.00 per share in cash for a total equity value of approximately $1.6 billion.

24 Nov 2008

Ortho Biotech submits NDA for Trabectedin in relapsed ovarian cancer

Ortho Biotech Products, L.P. has announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for trabectedin when administered in combination with DOXIL (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer (ROC).

20 Nov 2008

FDA approves GSK's Promacta (Eltrombopag)

GlaxoSmithKline has announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

20 Nov 2008

FDA accepts Vanda Pharmaceuticals Iloperidone resubmission

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, reported today that the FDA has accepted Vanda's resubmission of the iloperidone New Drug Application (NDA).

20 Nov 2008