Chartwell
FDA Approves ZIPRASIDONE — Chartwell RX, LLC
# FDA Approval Newswire The FDA has approved Chartwell RX, LLC's generic formulation of Ziprasidone Hydrochloride for oral administration, expanding ...
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Astellas
FDA Approves XTANDI — Astellas Pharma US, Inc.
Astellas Pharma US, Inc. received FDA approval for XTANDI (enzalutamide), an oral medication for prostate cancer, which historically generated over $4...
Aurobindo
FDA Approves ALFUZOSIN HYDROCHLORIDE — Aurobindo Pharma Limited
Aurobindo Pharma Limited received FDA approval for the generic formulation of its ALFUZOSIN HYDROCHLORIDE oral tablets, broadening the company’s portf...
Macleods
FDA Approves LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — Macleods Pharmaceuticals Limited
# FDA Approves Generic Losartan Potassium and Hydrochlorothiazide Combination Macleods Pharmaceuticals Limited received FDA approval for its generic ...
Alvogen,
FDA Approves OXYCODONE AND ACETAMINOPHEN — Alvogen, Inc.
Alvogen, Inc. received FDA approval on Thursday for a generic version of Oxycodone and Acetaminophen tablets, enabling the company to enter the establ...
Eugia
FDA Approves FLUOROURACIL — Eugia US LLC
# FDA Approves Fluorouracil IV from Eugia US LLC The FDA has approved Eugia US LLC's intravenous fluorouracil formulation (ANDA 202668), adding anoth...
Eugia
FDA Approves FLUOROURACIL — Eugia US LLC
# FDA Approves Generic Fluorouracil Intravenous Formulation The FDA approved Eugia US LLC's abbreviated new drug application for generic fluorouracil...
ACTAVIS
FDA Approves Unknown Drug — ACTAVIS ELIZABETH
Actavis Elizabeth announced today the approval of the ANDA091609, a generic drug that holds significant market potential to compete directly with esta...
Genentech,
FDA Approves PERJETA — Genentech, Inc.
# FDA Approves Genentech's PERJETA (Pertuzumab) for HER2-Positive Breast Cancer Genentech, Inc. has received FDA approval for PERJETA (pertuzumab), a...
Sun
FDA Approves ABSORICA — Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries’ 2012 approval of Absorica (isotretinoin) strengthened the company's market position in the dermatology sector by introd...
Mylan
FDA Approves ACETAZOLAMIDE — Mylan Institutional LLC
# FDA Approves Mylan Institutional's Intravenous Acetazolamide Sodium Formulation Mylan Institutional LLC received FDA approval for its intravenous a...
GLENMARK
FDA Approves Unknown Drug — GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd. received Abbreviated New Drug Application (ANDA) approval on May 4, 2012, clearing the company to produce and market the...
Teva
FDA Approves VARDENAFIL HYDROCHLORIDE — Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc. received FDA approval on May 3, 2012, for its ANDA 091347, enhancing competition in the sildenafil-alternative market f...
Dr.
FDA Approves OLANZAPINE — Dr. Reddy's Laboratories Inc.
# FDA Approves Dr. Reddy's Generic Olanzapine, Expanding Antipsychotic Competition Dr. Reddy's Laboratories Inc. received FDA approval for its generi...
Dr.
FDA Approves OLANZAPINE — Dr. Reddy's Laboratories Ltd.
# FDA Approves Dr. Reddy's Laboratories' Generic Olanzapine Dr. Reddy's Laboratories Ltd. received FDA approval for its generic olanzapine oral formu...
GRAVITI
FDA Approves Unknown Drug — GRAVITI PHARMS
# FDA Approves Generic Drug Application for Graviti Pharms Graviti Pharms has received FDA approval for ANDA201380, marking the company's entry into ...
Aurolife
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Aurolife Pharma, LLC
Aurolife Pharma, LLC received FDA approval for its Abbreviated New Drug Application for hydrocodone bitartrate and acetaminophen tablets on a recent d...
APOTEX
FDA Approves Unknown Drug — APOTEX INC
Apotex Inc. received FDA approval for Abbreviated New Drug Application (ANDA) #091308, signaling its entry into the market with a generic alternative ...
Teva
FDA Approves IRBESARTAN AND HYDROCHLOROTHIAZIDE — Teva Pharmaceuticals USA, Inc.
# FDA Approves Teva's Generic Irbesartan and Hydrochlorothiazide Combination Teva Pharmaceuticals USA, Inc. received FDA approval for a generic versi...
ALKEM
FDA Approves Unknown Drug — ALKEM LABS LTD
ALKEM LABS LTD secured an FDA approval for ANDA202076, a regulatory milestone expected to bolster the company's market presence and unlock significant...