New Drug Application News and Research

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Actavis settles patent litigation with AstraZeneca over generic version of Crestor

Actavis, Inc., a leading specialty pharmaceutical company, today announced that is has reached a settlement agreement with AstraZeneca resolving outstanding patent litigation related to Actavis' generic version of rosuvastatin calcium 5, 10, 20 and 40 mg tablets, the generic version of Crestor tablets, as well as Actavis' rosuvastatin zinc alternate salt product.

25 Mar 2013

Alnylam begins dosing in Phase I clinical trial with ALN-TTRsc for treatment of ATTR

Alnylam Pharmaceuticals a leading RNAi therapeutics company, announced today that it has initiated dosing in its Phase I clinical trial with ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

19 Mar 2013

Mylan gets final approval from FDA for generic Xopenex Inhalation Solution

Mylan Inc. today announced that its subsidiary Mylan Specialty L.P. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Levalbuterol Inhalation Solution USP, 0.31 mg/3 mL (0.0103%), 0.63 mg/3 mL (0.021%), and 1.25 mg/3 mL (0.042%), (Concentrate).

19 Mar 2013

Tivozanib: an interview with Stephen L. Eck, M.D., Ph.D., Vice President, Global Oncology, Astellas Pharma US, Inc. Global Development

Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor, or TKI, that is being investigated for use in patients with advanced renal cell carcinoma (RCC), or kidney cancer.

19 Mar 2013

FDA accepts AMAG’s Feraheme sNDA for review

AMAG Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted for review the company's supplemental new drug application (sNDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use, which was submitted to the FDA in December 2012.

6 Mar 2013

Two novel radiolabeled small molecules can help detect prostate cancer

Two novel radiolabeled small molecules targeting prostate-specific membrane antigen (PSMA) have excellent potential for further development as diagnostic and therapeutic radiopharmaceuticals, according to research published this month in The Journal of Nuclear Medicine.

6 Mar 2013

Positive results from Anacor’s second of two Phase 3 trials of tavaborole for onychomycosis

Anacor Pharmaceuticals today announced positive preliminary results from the second of two Phase 3 trials of tavaborole (known as Study 302).

28 Feb 2013

FDA accepts Antares Pharma's New Drug Application for OTREXUP

Antares Pharma, Inc. today announced that the New Drug Application for OTREXUP, a potential new product for the subcutaneous delivery of methotrexate using Medi-Jet technology, has been accepted by the U.S. Food and Drug Administration indicating that the application is sufficiently complete to permit a substantive review.

27 Feb 2013

FDA's Oncologic Drugs Advisory Committee to review NDA for tivozanib

AVEO Oncology and Astellas Pharma Global Development, Inc., a U.S. subsidiary of Tokyo-based Astellas Pharma Inc., today announced that the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee will review the company's New Drug Application for tivozanib for the treatment of patients with advanced renal cell carcinoma during the morning session of its meeting on May 2, 2013.

27 Feb 2013

High-level results from AstraZeneca’s naloxegol Phase III trial on opioid-induced constipation

AstraZeneca today announced high-level results from KODIAC-08, an open-label, randomised, 52-week, long-term safety trial of naloxegol versus usual care (UC) in patients with non-cancer related pain and opioid-induced constipation (OIC). UC was defined as the investigator's choice of an existing laxative treatment regimen for OIC.

26 Feb 2013

FDA approves Actavis’ generic Suboxone ANDA to treat opioid dependence

Actavis, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone.

26 Feb 2013

FDA approves Lupin Pharmaceuticals' SUPRAX for Oral Suspension

Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received approval for SUPRAX (Cefixime) for Oral Suspension, 500 mg/5mL from the United States Food and Drugs Administration (FDA).

23 Feb 2013

FDA committee recommends approval of Guerbet’s Dotarem NDA for adults and children

Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem (gadoterate meglumine) for adults, and for pediatric use for children two years of age and older.

15 Feb 2013

Mallinckrodt, Actavis enter settlement agreement to resolve Exalgo patent litigation

Actavis, Inc. today announced that it has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Actavis' generic version of the 32 mg dosage strength of Mallinckrodt's Exalgo (Hydromorphone Hydrochloride Extended-Release) tablets.

15 Feb 2013

FDA approves Teva’s generic Adderall XR ANDA for treatment of ADHD

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shire's Adderall XR Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder.

14 Feb 2013

FDA acknowledges United Therapeutics’ oral treprostinil NDA to treat PAH

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension.

14 Feb 2013

FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

Breckenridge Pharmaceutical, Inc. announced today the immediate launch of Pioglitazone Hydrochloride Tablets. The U.S. Food and Drug Administration granted final approval for the Abbreviated New Drug Application (ANDA), which is being manufactured and supplied by Synthon Pharmaceuticals, Inc., and will be available in 15 mg, 30 mg, and 45 mg strengths.

14 Feb 2013

Tivozanib overall survival results announced by AVEO and Astellas

AVEO Oncology (NASDAQ: AVEO) and Astellas Pharma Inc. (TSE: 4503) announced overall survival (OS) for tivozanib, an investigational agent, from the Phase 3 TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) study in patients with advanced renal cell carcinoma (RCC). The final OS analysis, as specified by the protocol, shows a median OS of 28.8 months (95% confidence interval [CI]: 22.5–NA) for tivozanib versus a median OS of 29.3 months (95% CI: 29.3–NA) for the comparator arm, sorafenib.

13 Feb 2013

Sucampo, R-Tech Ueno and Takeda file patent infringement lawsuit against Anchen for AMITIZA

Sucampo Pharmaceuticals, Inc. announced that it, together with R-Tech Ueno, Ltd., Sucampo AG, and Takeda Pharmaceutical Company Limited and certain affiliates of Takeda, has filed a patent infringement lawsuit against Anchen Pharmaceuticals, Inc., which had filed Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA (lubiprostone) oral capsules, and certain affiliates of Anchen.

12 Feb 2013

Shire, Impax resolve pending generic Adderall XR litigation

Impax Laboratories, Inc. today announced that it has settled all pending litigation with Shire LLC and Shire Laboratories, Inc. relating to supply of its authorized generic Adderall XR under the parties' License and Distribution Agreement that was signed in January 2006.

10 Feb 2013

New Drug Application News and Research

Actavis settles patent litigation with AstraZeneca over generic version of Crestor

Alnylam begins dosing in Phase I clinical trial with ALN-TTRsc for treatment of ATTR

Mylan gets final approval from FDA for generic Xopenex Inhalation Solution

Tivozanib: an interview with Stephen L. Eck, M.D., Ph.D., Vice President, Global Oncology, Astellas Pharma US, Inc. Global Development

FDA accepts AMAG’s Feraheme sNDA for review

Two novel radiolabeled small molecules can help detect prostate cancer

Positive results from Anacor’s second of two Phase 3 trials of tavaborole for onychomycosis

FDA accepts Antares Pharma's New Drug Application for OTREXUP

FDA's Oncologic Drugs Advisory Committee to review NDA for tivozanib

High-level results from AstraZeneca’s naloxegol Phase III trial on opioid-induced constipation

FDA approves Actavis’ generic Suboxone ANDA to treat opioid dependence

FDA approves Lupin Pharmaceuticals' SUPRAX for Oral Suspension

FDA committee recommends approval of Guerbet’s Dotarem NDA for adults and children

Mallinckrodt, Actavis enter settlement agreement to resolve Exalgo patent litigation

FDA approves Teva’s generic Adderall XR ANDA for treatment of ADHD

FDA acknowledges United Therapeutics’ oral treprostinil NDA to treat PAH

FDA grants final approval to Breckenridge’s Pioglitazone Hydrochloride ANDA

Tivozanib overall survival results announced by AVEO and Astellas

Sucampo, R-Tech Ueno and Takeda file patent infringement lawsuit against Anchen for AMITIZA

Shire, Impax resolve pending generic Adderall XR litigation

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The role of UV-Vis in biopharma QC

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