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Lotus Pharmaceuticals' asthma drug Laevo-Bambutero to receive Chinese SFDA Fast Track Approval

Lotus Pharmaceuticals, Inc., a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China reported that its asthma drug Laevo-Bambutero will receive the China's State Food & Drug Administration's (SFDA) Fast Track Approval to enter clinical trials. The SFDA's Drug Review and Evaluation Center told the Company during recent consultations at the end of the Company's IND that formal approval would be granted by the Beijing office of the SFDA.

21 Apr 2010

Elan's first-quarter total revenue up by 27% to $310.5M

Elan Corporation, plc, today reported its first quarter 2010 financial results.

21 Apr 2010

Forest Laboratories' fourth-quarter net sales up 11.0% to $995.6M

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that diluted earnings per share equaled $0.07 in the fourth quarter of fiscal 2010.

21 Apr 2010

Celsion's ThermoDox Phase I trial data presented at 9th IHPBA World Congress

Celsion Corporation today announced that Dr. Thanjavur S. Ravikumar, from the Geisinger Health System and a principal investigator of the Phase I ThermoDox® dose escalation trial, gave an oral presentation at the Liver Tumors Panel session of the 9th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA) in Buenos Aires, Argentina.

21 Apr 2010

FDA approves Lannett's ANDA for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials

Lannett Company, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials. Ondansetron Injection USP, 2 mg/mL is the generic equivalent of GlaxoSmithKline's Zofran® Injection, 2 mg/mL. For the 12 months ending December 2009 U.S. sales of Ondansetron Injection USP, 2 mg/mL were approximately $58 million at Average Wholesale Price (AWP). A launch date for the product has not yet been set.

20 Apr 2010

Matrix Laboratories' ANDA for Didanosine Delayed-release Capsules receives FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Didanosine Delayed-release Capsules, 125 mg, 200 mg, 250 mg and 400 mg, the generic version of Bristol Myers Squibb's HIV treatment Videx® EC.

19 Apr 2010

Amylin Pharmaceuticals announces $174.1M total revenue for first-quarter 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended March 31, 2010. The Company reported total revenue of $174.1 million for the quarter ended March 31, 2010, which includes net product sales of $172.3 million. Non-GAAP operating loss was $3.8 million for the quarter ended March 31, 2010, compared to $19.9 million for the same period in 2009.

19 Apr 2010

NDA for Cadence Pharmaceuticals' OFIRMEV injection to be re-submitted to FDA

Cadence Pharmaceuticals, Inc. announced today that, based on feedback received during a meeting with the U.S. Food and Drug Administration on April 16, 2010, it plans to re-submit a New Drug Application for its investigational product candidate, OFIRMEV (acetaminophen) injection, within the next 30 days.

19 Apr 2010

Repligen expects total revenue of $21.0M for fiscal year 2010

Repligen Corporation today announced preliminary financial results for fiscal year 2010 which ended March 31, 2010. Total revenue for the year is expected to be $21.0 million, including $10.3 million of bioprocessing product revenue and $10.7 million of royalty and other revenue. Research and development expenses are expected to be between $13.8-$14.2 million and selling, general and administrative expenses between $6.8-$7.2 million.

16 Apr 2010

Alexion Pharmaceuticals' Soliris NDA for PNH receives approval in Japan

Alexion Pharmaceuticals, Inc. and Alexion Pharma International Sàrl today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the Company's New Drug Application (NDA) for the use of Soliris® (eculizumab) as a treatment for patients in Japan with paroxysmal nocturnal hemoglobinuria (PNH).

16 Apr 2010

InterMune reports Phase 1b MAD study results of RTV-boosted danoprevir in HCV patients at 45th EASL

InterMune, Inc. today announced results of all three cohorts from a 15-day Phase 1b multiple-ascending-dose (MAD) study of low doses of danoprevir (also known as RG7227 and ITMN-191) boosted by low-dose ritonavir (RTV) in patients chronically infected with hepatitis C virus (HCV) genotype-1.

16 Apr 2010

Celsion announces presentation of long-term follow-up data from Phase I ThermoDox dose escalation trial

Celsion Corporation today announced that Dr. Ronnie T.P. Poon, a principal investigator of the Phase I ThermoDox® dose escalation trial, held a press conference at the University of Hong Kong to provide an update on the long-term follow-up data from patients treated at his center as well as present illustrative patient case studies. The Phase I trial was conducted in 2006.

16 Apr 2010

FDA approves Akorn's ANDA for generic version of Dilaudid-HP Injection

Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted approval of the Company's Abbreviated New Drug Application for the generic version of Dilaudid-HP® 10mg/ml Injection. The company intends to begin shipping the product next month.

16 Apr 2010

Watson Laboratories' ANDA for generic Toprol XL tablets receives FDA approval

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc. - Florida, has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for metoprolol succinate extended-release tablets USP in the 100 and 200 mg strengths, the generic equivalent to AstraZeneca's Toprol XL® tablets.

16 Apr 2010

Enrollment completed in Impax Pharmaceuticals' APEX-PD trial of IPX066

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc., today announced that it has completed enrollment of its APEX-PD trial. APEX-PD is a multinational Phase III trial of its late-stage drug candidate IPX066 in subjects with early Parkinson's disease.

16 Apr 2010

POZEN enters Settlement Agreement with Teva over generic Treximet ANDA patent infringement litigation

POZEN Inc., today announced that it has entered into a Settlement Agreement with Teva Pharmaceuticals USA, Inc. (Teva) to resolve a U.S. patent infringement suit related to Teva's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of Treximet® (sumatriptan/naproxen sodium) marketed by POZEN's exclusive U.S. licensee, GlaxoSmithKline.

15 Apr 2010

FDA approves Sagent Pharmaceuticals' two ANDAs to market granisetron

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced the U.S. Food and Drug Administration has approved the Company's two abbreviated New Drug Applications to market granisetron hydrochloride injection, USP (granisetron), an antiemetic used to prevent nausea and vomiting caused by chemotherapy.

15 Apr 2010

FDA approves J&JPRD's PANCREAZE NDA

Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for PANCREAZE™ (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars.

15 Apr 2010

Alkermes submits VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence. The company requested a priority review for its sNDA and if granted by the FDA, it would mean a six month review timeline.

13 Apr 2010

Clinical trial data on AMPYRA Extended Release Tablets to be presented at AAN Annual meeting

Acorda Therapeutics, Inc. today announced that four new analyses of clinical trial data on AMPYRA™ (dalfampridine) Extended Release Tablets 10 mg are being presented at the 62nd American Academy of Neurology Annual meeting.

13 Apr 2010

New Drug Application News and Research

Lotus Pharmaceuticals' asthma drug Laevo-Bambutero to receive Chinese SFDA Fast Track Approval

Elan's first-quarter total revenue up by 27% to $310.5M

Forest Laboratories' fourth-quarter net sales up 11.0% to $995.6M

Celsion's ThermoDox Phase I trial data presented at 9th IHPBA World Congress

FDA approves Lannett's ANDA for Ondansetron Injection USP, 2 mg/mL, Multi-Dose Vials

Matrix Laboratories' ANDA for Didanosine Delayed-release Capsules receives FDA approval under PEPFAR

Amylin Pharmaceuticals announces $174.1M total revenue for first-quarter 2010

NDA for Cadence Pharmaceuticals' OFIRMEV injection to be re-submitted to FDA

Repligen expects total revenue of $21.0M for fiscal year 2010

Alexion Pharmaceuticals' Soliris NDA for PNH receives approval in Japan

InterMune reports Phase 1b MAD study results of RTV-boosted danoprevir in HCV patients at 45th EASL

Celsion announces presentation of long-term follow-up data from Phase I ThermoDox dose escalation trial

FDA approves Akorn's ANDA for generic version of Dilaudid-HP Injection

Watson Laboratories' ANDA for generic Toprol XL tablets receives FDA approval

Enrollment completed in Impax Pharmaceuticals' APEX-PD trial of IPX066

POZEN enters Settlement Agreement with Teva over generic Treximet ANDA patent infringement litigation

FDA approves Sagent Pharmaceuticals' two ANDAs to market granisetron

FDA approves J&JPRD's PANCREAZE NDA

Alkermes submits VIVITROL sNDA for opioid dependence

Clinical trial data on AMPYRA Extended Release Tablets to be presented at AAN Annual meeting

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