FDA Approves QUILLIVANT XR — NextWave Pharmaceuticals, Inc
# FDA Approves NextWave Pharmaceuticals' QUILLIVANT XR for ADHD Treatment NextWave Pharmaceuticals, Inc. received FDA approval for QUILLIVANT XR (methylphenidate hydrochloride), a…
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# FDA Approves NextWave Pharmaceuticals' QUILLIVANT XR for ADHD Treatment NextWave Pharmaceuticals, Inc. received FDA approval for QUILLIVANT XR (methylphenidate hydrochloride), a…
# FDA Approves Sandoz Generic Drug Application Sandoz received FDA approval for ANDA 077446 on September 27, 2012, expanding its generic pharmaceutical portfolio and positioning t…
# FDA Approves Losartan Potassium Generic from Micro Labs Limited Micro Labs Limited has received FDA approval for its generic formulation of losartan potassium, an oral antihyper…
Lupin Pharmaceuticals, Inc. secured FDA approval for generic Escitalopram Oxalate oral tablets, expanding its portfolio in the widely utilized antidepressant market. This regulator…
# FDA Approval Newswire The FDA has approved Chartwell RX, LLC's generic formulation of Ziprasidone Hydrochloride for oral administration, expanding the competitive landscape in t…
Astellas Pharma US, Inc. received FDA approval for XTANDI (enzalutamide), an oral medication for prostate cancer, which historically generated over $4 billion in annual revenue bef…
Aurobindo Pharma Limited received FDA approval for the generic formulation of its ALFUZOSIN HYDROCHLORIDE oral tablets, broadening the company’s portfolio and introducing immediate…
# FDA Approves Generic Losartan Potassium and Hydrochlorothiazide Combination Macleods Pharmaceuticals Limited received FDA approval for its generic losartan potassium and hydroch…
Alvogen, Inc. received FDA approval on Thursday for a generic version of Oxycodone and Acetaminophen tablets, enabling the company to enter the established market for this widely p…
# FDA Approves Fluorouracil IV from Eugia US LLC The FDA has approved Eugia US LLC's intravenous fluorouracil formulation (ANDA 202668), adding another generic option to the compe…
# FDA Approves Generic Fluorouracil Intravenous Formulation The FDA approved Eugia US LLC's abbreviated new drug application for generic fluorouracil intravenous injection on July…
# FDA Approves Genentech's PERJETA (Pertuzumab) for HER2-Positive Breast Cancer Genentech, Inc. has received FDA approval for PERJETA (pertuzumab), a novel HER2-targeted therapy a…
Sun Pharmaceutical Industries’ 2012 approval of Absorica (isotretinoin) strengthened the company's market position in the dermatology sector by introducing a branded generic altern…
# FDA Approves Mylan Institutional's Intravenous Acetazolamide Sodium Formulation Mylan Institutional LLC received FDA approval for its intravenous acetazolamide sodium formulatio…
Glenmark Pharmaceuticals Ltd. received Abbreviated New Drug Application (ANDA) approval on May 4, 2012, clearing the company to produce and market the generic version of the releva…
Teva Pharmaceuticals USA, Inc. received FDA approval on May 3, 2012, for its ANDA 091347, enhancing competition in the sildenafil-alternative market following the patent cliff for …
# FDA Approves Dr. Reddy's Generic Olanzapine, Expanding Antipsychotic Competition Dr. Reddy's Laboratories Inc. received FDA approval for its generic olanzapine oral formulation,…
# FDA Approves Dr. Reddy's Laboratories' Generic Olanzapine Dr. Reddy's Laboratories Ltd. received FDA approval for its generic olanzapine oral formulation on April 23, 2012, expa…
# FDA Approves Generic Drug Application for Graviti Pharms Graviti Pharms has received FDA approval for ANDA201380, marking the company's entry into the generic pharmaceutical mar…
Aurolife Pharma, LLC received FDA approval for its Abbreviated New Drug Application for hydrocodone bitartrate and acetaminophen tablets on a recent date, likely increasing generic…