Eli Lilly Drops Glenmark In $500M ADHD Drug Suit

Eli Lilly and Co. agreed to drop patent infringement charges against generics maker Glenmark Pharmaceuticals Inc. USA as long as Glenmark adheres to any future rulings regarding a generic version of Strattera, an Eli Lilly drug used to treat attention deficit hyperactivity disorder.

(Source: www.iplaw360.com)

Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol

Labopharm Inc. today announced that it has submitted a complete response to the Food and Drug Administration (FDA) per the suggestion of Dr. Douglas Throckmorton, M.D., the FDA's Deputy Director, Center for Drug Evaluation and Research (CDER), as the next step in the regulatory path towards potential U.S. approval of the Company's once-daily formulation of tramadol. The complete response centers on the additional analysis of existing data using the methodology put forward by Dr. John K. Jenkins, M.D., Director for the Office of New Drugs, CDER, in his letter earlier this year.

The details can be read here.

GeneraMedix Inc. Receives Approval for Epoprostenol for Injection 1.5 mg

On June 27, 2008 GeneraMedix Inc. received approval from the U.S. Food and Drug Administration (FDA) for its Epoprostenol for Injection 1.5 mg New Drug Application (NDA).
Epoprostenol for Injection 1.5 mg is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.

The details can be read here.

Wyeth and Progenics Receive Approval from European Commission for Relistor for Opioid-Induced Constipation in Advanced Illness Patients

Jul 3, 2008 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies have received marketing approval for RELISTOR(TM) (methylnaltrexone bromide) subcutaneous injection from the European Commission. RELISTOR is now approved in the 27 member states of the European Union as well as Iceland, Norway, and Liechtenstein for the treatment of opioid-induced constipation (OIC) in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient. RELISTOR is the first approved treatment for OIC in the European Union.

The details can be read here.

APP Pharmaceuticals Receives Final Approvals for Additional Dosages of Granisetron Hydrochloride Injection, USP

July 3, 2008 - APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received final approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic equivalent of Hoffmann-LaRoche's Kytril(R) Injection. According to IMS data, branded sales of these two dosage forms of Granisetron were approximately $72.2 million in 2007. The company currently markets Granisetron in 0.1 mg/mL, 1 mL single dose vials and will commence distributing the 1 mg/mL, 1 mL single dose, and 1mg/mL, 4 mL multiple dose vials immediately. All of APP's Granistron products are AP-rated, preservative and latex-free, and bar-coded.
Granisetron Hydrochloride Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high dose cisplatin and radiation cancer therapy. Granisetron Hydrochloride Injection is also indicated for the prevention of postoperative nausea and/or vomiting.

Mylan Announces Tentative FDA Approval for Generic Version of Antibiotic Zyvox Tablets

Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Linezolid Tablets, 600 mg.
Linezolid Tablets, an antibiotic, are the generic version of Pharmacia and Upjohn's Zyvox(R) Tablets, which had U.S. sales of approximately $422 million for the 12 months ending March 31, 2008, according to IMS Health.
Currently, Mylan has 93 ANDAs pending FDA approval, 21 of which are potential first-to-file opportunities.

Glenmark acquires 7 brands to foray into Polish market

Glenmark Pharmaceuticals Ltd. (India) has announced that its European organisation, acting through its Czech subsidiary Medicamenta, has signed agreements with Actavis, the international generic pharmaceutical company from Iceland, and Biovena (an affiliate of Actavis in Poland) to acquire 7 pharmaceutical brands in Poland with effect from July 1, 2008. The acquisition of the products from these two different companies for an undisclosed sum will provide Glenmark its first access to the growing Polish market, the largest pharmaceutical market in Central & East Europe.
The details can be read here.

FDA Approves Aciphex (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents

Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.
The details can be read here.

EMEA Confirms Positive Benefit-Risk Balance with Raptiva for the Treatment of Psoriasis

July 1, 2008 – Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the European Commission has approved an update of the Summary of Product Characteristics (SPC) for Raptiva® (efalizumab) in the treatment of moderate-to-severe chronic plaque psoriasis, a chronic inflammatory systemic disease of the skin. The decision followed a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which had previously completed a benefit-risk re-assessment of Raptiva®. The CHMP had concluded, based on the clinical and post-marketing data submitted by Merck Serono, that the benefit-risk profile remains positive for the population in the approved indication.

The details can be read here.

Bioniche Pharma Acquires Baxter's ENLON and ENLON-PLUS

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, announced today the acquisition of Baxter Healthcare Corporation's ENLON product line, including: -- ENLON(R) (edrophonium chloride injection, USP) 10 mg/mL, 15 mL vial
-- ENLON-PLUS(R) (edrophonium chloride, USP and atropine sulfate, USP) Injection 5 mL ampule
-- ENLON-PLUS(R) (edrophonium chloride, USP and atropine sulfate, USP) Injection, 15 mL Multi-dose Vial.

The details can be read here.

Summary Judgment Granted for Seroquel Patent Litigation

AstraZeneca today announced that the US District Court for the District of New Jersey has granted the company's Motion for Summary Judgment of No Inequitable Conduct. AstraZeneca had sued Teva Pharmaceutical Industries Ltd. and Sandoz, Inc. alleging infringement of AstraZeneca's patent as a result of Teva's and Sandoz's filings of Abbreviated New Drug Applications (ANDAs). The ANDAs sought approval to market generic versions of SEROQUEL(R) (quetiapine fumarate) tablets in the US before SEROQUEL's patent expires in 2011. Since the Court granted AstraZeneca's motion for Summary Judgment of No Inequitable Conduct in its entirety, trial is unnecessary.

The details can be read here.

Teva Receives First U.S. Approval for Generic Risperdal Tablets; Commences Commercial Launch

Jun 30, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Janssen's antipsychotic agent Risperdal(R) (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Shipment of these products has commenced.

As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.

The details can be read here.

Teva Introduces Granisetron Hydrochloride Injection in Multiple Dose Vials

June 30, 2008 – Teva Health Systems is pleased to announce the introductionand availability of Granisetron Hydrochloride Injection in 4 mL multiple dose vials. This Tevaproduct is AP rated to Kytril®* Injection. With the addition of this new size, Teva now offersGranisetron Hydrochloride Injection in 0.1 mg/mL, 1 mL vials, and 1 mg/mL, 1 mL and 4 mL vials.“Our customers look to us for a continuous supply of new health systems generics,” states JenniferGuzman, Director of Commercial Operations. “Teva’s commitment to new product developmentassures important products like Granisetron are available on a timely basis.”Teva Health Systems is a part of Teva Pharmaceuticals, the leading pharmaceutical manufacturerfor both new and total prescriptions.‡ The company has an aggressive Research and Developmenteffort and one of the best overall ANDA approval records in the industry.

Janssen Announces Launch of Authorized Generic for Risperdal

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced that it has launched an authorized generic version of RISPERDAL(R) (risperidone) through Patriot Pharmaceuticals, L.L.C. Patriot is a subsidiary of McNeil-PPC. Both companies are a part of the Johnson & Johnson family of companies.

The details can be read here.

Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA

The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the ANDA filer sent its notice letter prematurely, before FDA had accepted the ANDA for filing. The case concerns Mutual Pharmaceutical's generic version of GlaxoSmithKline's heart medication Coreg CR (carvedilol phosphate).
The details can be read here.