Cipla
FDA Approves ATORVASTATIN CALCIUM — Cipla USA Inc.,
The FDA has approved a supplementary ANDA for oral atorvastatin calcium by Cipla USA Inc., allowing the company to expand its generic cholesterol-lowe...
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Genentech,
FDA Approves TECENTRIQ — Genentech, Inc.
# FDA Approves Genentech's TECENTRIQ (atezolizumab) for Bladder Cancer Genentech, Inc. received FDA approval for TECENTRIQ (atezolizumab), a PD-L1 in...
PHARMOBEDIENT
FDA Approves Unknown Drug — PHARMOBEDIENT
Pharmobedient Continues Regulatory Expansion Pharmobedient has expanded its product portfolio with this latest FDA approval, positioning itself for br...
Aurolife
FDA Approves OXYMORPHONE HYDROCHLORIDE — Aurolife Pharma, LLC
Aurolife Pharma, LLC announced the FDA approval of its OxyMORPHONE HYDROCHLORIDE tablets, increasing generic availability in the opioid market and fac...
Collegium
FDA Approves XTAMPZA ER — Collegium Pharmaceutical, Inc.
Collegium Pharmaceutical, Inc. capitalized on the FDA's April 26, 2016 approval of its XTAMPZA ER extended-release opioid, positioning itself for sign...
AMNEAL
FDA Approves Unknown Drug — AMNEAL PHARMS
# FDA Approves Amneal Pharmaceuticals Generic Drug Application Amneal Pharmaceuticals received FDA approval for ANDA205081 on April 22, 2016, expandi...
Sandoz
FDA Approves MEROPENEM — Sandoz Inc
# FDA Approves Sandoz's Generic Meropenem for Intravenous Use Sandoz Inc. has received FDA approval for its generic meropenem injection, expanding th...
Amneal
FDA Approves MORPHINE SULFATE — Amneal Pharmaceuticals of New York LLC
# FDA Approves Amneal Pharmaceuticals' Generic Morphine Sulfate Oral Formulation Amneal Pharmaceuticals of New York LLC received FDA approval for its...
Rhodes
FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Rhodes Pharmaceuticals LLC
Rhodes Pharmaceuticals received FDA approval for the ANDA for its generic version of Hydrocodone Bitartrate and Acetaminophen, a move that is expected...
AbbVie
FDA Approves VENCLEXTA — AbbVie Inc.
# FDA Approves AbbVie's VENCLEXTA (venetoclax) for Chronic Lymphocytic Leukemia AbbVie Inc. received FDA approval for VENCLEXTA (venetoclax), an oral...
Amneal
FDA Approves DESIPRAMINE HYDROCHLORIDE — Amneal Pharmaceuticals NY LLC
# FDA Approves Desipramine Hydrochloride Generic Amneal Pharmaceuticals NY LLC has received FDA approval for its generic desipramine hydrochloride or...
Pfizer
FDA Approves XELJANZ XR — Pfizer Laboratories Div Pfizer Inc
On February 23, 2016, the FDA granted approval to Pfizer's oral TOFACITINIB CITRATE for XELJANZ XR, marking a strategic expansion of the rheumatoid ar...
ScieGen
FDA Approves GABAPENTIN — ScieGen Pharmaceuticals, Inc.
# FDA Approves ScieGen Pharmaceuticals' Generic Gabapentin ScieGen Pharmaceuticals, Inc. received FDA approval for its generic gabapentin oral formul...
Sagent
FDA Approves FLUOROURACIL — Sagent Pharmaceuticals
# FDA Approves Sagent Pharmaceuticals' Generic Fluorouracil Injection Sagent Pharmaceuticals has received FDA approval for its generic fluorouracil i...
ACCORD
FDA Approves Unknown Drug — ACCORD HLTHCARE
# FDA Approves ANDA Submission for Accord Healthcare Accord Healthcare has received FDA approval for its abbreviated new drug application (ANDA206058...
Creekwood
FDA Approves GABAPENTIN — Creekwood Pharmaceuticals LLC
# FDA Approves Generic Gabapentin from Creekwood Pharmaceuticals Creekwood Pharmaceuticals LLC has received FDA approval for its generic gabapentin o...
Eugia
FDA Approves TRANEXAMIC ACID — Eugia US LLC
Eugia US LLC received FDA approval for its ANDA for tranexamic acid intravenous injection (2016), a generic version of the marketed hemostatic agent. ...
Macleods
FDA Approves LEVOCETIRIZINE DIHYDROCHLORIDE — Macleods Pharmaceuticals Limited
# FDA Approves Macleods Pharmaceuticals' Generic Levocetirizine Dihydrochloride Macleods Pharmaceuticals Limited received FDA approval for its generi...
MYLAN
FDA Approves Unknown Drug — MYLAN
Mylan has received regulatory approval from the FDA for a new generic product through ANDA 205257, signaling a potential new revenue opportunity for t...
Actelion
FDA Approves UPTRAVI — Actelion Pharmaceuticals US, Inc.
# FDA Approves Actelion Pharmaceuticals' UPTRAVI for Pulmonary Arterial Hypertension Actelion Pharmaceuticals US, Inc. received FDA approval for UPTR...