Pharmasset Reports Fiscal Year End 2007 Financial Results
PRINCETON, N.J., Dec. 31 /Pharmasset, Inc.
(Nasdaq: VRUS), a clinical stage pharmaceutical company committed to
discovering, developing and commercializing novel drugs to treat viral
infections, reported audited financial results for the fiscal year ended
September 30, 2007. Pharmasset reported a net loss attributable to common
stockholders of $6.8 million, or $0.46 per share, as compared to a net loss
attributable to [...]
Cephalon Submits New Drug Application for TREANDA for the Treatment of Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma
FRAZER, Pa., Dec. 31 / Cephalon, Inc. (Nasdaq:
CEPH) today announced that it has submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) requesting approval of
TREANDA(R) (bendamustine HCl) for Injection for the treatment of patients
with indolent B-cell non-Hodgkin’s lymphoma (NHL) who have progressed
during or following treatment with rituximab or a rituximab-containing
regimen. According [...]
Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Tablets (OTC), 5mg and 10mg
PRINCETON, N.J., Dec. 31 /Ranbaxy Laboratories Limited
(RLL), announced today that the company has received final approval from
the U.S. Food and Drug Administration to manufacture and market Cetirizine
Hydrochloride Tablets (OTC), 5 mg and 10 mg. The Office of Generic Drugs,
U.S. Food and Drug Administration, has determined the Ohm formulation to be
bioequivalent and have the same therapeutic [...]
IDM Pharma Announces Termination of UVIDEM Development Collaboration and Expected Restructuring in Connection With Evaluation of Strategic Alternatives
IRVINE, Calif., Dec. 31 / IDM Pharma, Inc.
(Nasdaq: IDMI) today announced that as part of the Company’s recent
decision to evaluate strategic alternatives, the Company initiated
discussions with sanofi-aventis. Following this, sanofi-aventis has
notified the Company of its decision to discontinue participation in the
development of UVIDEM, its investigational therapy being studied for the
treatment of melanoma, with all rights [...]
Mylan Announces Final FDA Approval for Balsalazide Disodium Capsules
PITTSBURGH, Dec. 31 /Mylan Inc. (NYSE: MYL) today
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 Balsalazide Disodium Capsules, 750 mg.
Balsalazide Disodium Capsules are the generic version of Salix
Pharmaceuticals’ Colazal(R) Capsules, which had U.S. sales of approximately
$130.9 million for the [...]
Forest and Cypress Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
NEW YORK and SAN DIEGO, Dec. 31 — Forest
Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB)
announced that they have recently submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for milnacipran, a unique
dual-reuptake inhibitor being developed for the treatment of fibromyalgia
syndrome (FMS).
FMS is defined by widespread chronic pain, as [...]
WuXi PharmaTech (NYSE: WX) Mourns the Tragic Loss of Its Independent Director Shawn Wang
WuXi PharmaTech (NYSE: WX), China’s premier provider of pharmaceutical R&D
outsourcing services, sadly announced today one of its independent
directors, Mr. Shawn Wang, Chief Financial Officer of Baidu, passed away in
an accident during his vacation on December 27, 2007.
Mr. Shawn Wang was appointed as an independent director on WuXi
PharmaTech’s Board of Directors in July, 2007 when the [...]
Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R)
Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug
Administration (FDA) has granted final approval for the Company’s
Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride
Tablets, “over the counter”, (OTC), 5 mg and 10 mg, (Cetirizine HCl).
Cetirizine HCl, which will be marketed as two separate OTC products in
two strengths of 5 [...]
Perrigo Announces FDA Approval for Over-The-Counter Cetirizine Hydrochloride Tablets
Perrigo Company (Nasdaq: PRGO; TASE) today 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.
The product will be marketed under store brand labels and is comparable
to McNeil Consumer Healthcare’s Cetirizine Hydrochloride Tablets, 5 and 10
mg, [...]
KV Pharmaceutical Company Announces NYSE Listing Extension
KV Pharmaceutical Company
(NYSE: KVa/KVb) a fully integrated specialty pharmaceutical company that
develops, manufactures, acquires and markets technology differentiated
branded and generic/non-branded prescription pharmaceutical products,
announced today that NYSE Regulation, Inc. has granted KV’s request for a
trading extension through February 15, 2008 for its securities, subject to
ongoing reassessment. The extension was required under the NYSE’s rules
because the Company has [...]
