FDA Approves MERCAPTOPURINE — Nova Laboratories, Ltd
Nova Laboratories has received FDA approval for the oral formulation of mercaptopurine (NDA205919), expanding an existing treatment portfolio during the vulnerable window of pediat…
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Nova Laboratories has received FDA approval for the oral formulation of mercaptopurine (NDA205919), expanding an existing treatment portfolio during the vulnerable window of pediat…
Senores Pharma secured FDA approval for its generic product, a move that is expected to bolster the company’s revenue stream while introducing immediate competitive pressure within…
Lantheus Biosciences has received FDA approval of NEURACEQ® (florbetaben F 18), a molecular imaging agent indicated for the detection of amyloid plaques in the brain. This authoriz…
# FDA Approves Upsher-Smith's Topiramate Oral Formulation Upsher-Smith Laboratories, LLC received FDA approval for its oral topiramate formulation (NDA 205122) on March 11, 2014, …
Lupin Pharmaceuticals, Inc. secured FDA approval on March 5, 2014, for its generic Doxycycline oral tablets, positioning the company to capture market share in the commodity antibi…
# FDA Approval Newswire Washington University School of Medicine has received FDA approval for AMMONIA N-13 (NH3N13), an intravenous diagnostic radiopharmaceutical that expands th…
Sankalp Lifecare announced FDA approval for its new drug application, a milestone that is expected to diversify the company's revenue streams and strengthen its competitive positio…
# FDA Approves AstraZeneca's FARXIGA for Diabetes Treatment AstraZeneca Pharmaceuticals LP received FDA approval for FARXIGA (dapagliflozin), an oral diabetes medication that expa…
Sun Pharma received FDA approval for an Abbreviated New Drug Application, a regulatory clearance expected to facilitate generic market entry and drive incremental revenue growth.
Par Health USA, LLC has secured FDA approval for injection, epinephrine, intended for the management of severe allergic reactions, historically opening the market for older-formula…
Mylan Pharmaceuticals Inc. received FDA approval for its generic version of the cardiovascular drug Amlodipine and Atorvastatin, offering a cost-effective alternative to branded co…
Fresenius Kabi secured FDA approval for its intramuscular morphine sulfate formulation, significantly expanding its therapeutic options within the competitive injectable analgesics…
Westminster Pharmaceuticals, LLC announced final FDA approval today for its ANDA 203769, aiming to introduce metformin hydrochloride tablets to the market. This move positions the …
# FDA Approves ANDA for AUROLIFE PHARMA LLC AUROLIFE PHARMA LLC has received FDA approval for ANDA 202580, expanding its generic drug portfolio and positioning the company to capt…
HIKMA Pharmaceuticals announced the FDA approval of its Generic ANDA application, a strategic milestone expected to bolster market share and expand revenue within the competitive U…
Aurolife Pharma, LLC announced the approval of an abbreviated new drug application ORAL OXYCODONE AND ACETAMINOPHEN, paving the way for its entry into the mid-level generic opioid …
HIKMA announced early FDA approval for its generic version of this pharmaceutical product on July 12, 2013, positioning itself to compete in this specific therapeutic market segmen…
PH HEALTH has secured FDA approval for the pending generic application ANDA090733, a move that positions the company to capture new market share and diversify its revenue streams u…
Actavis Elizabeth’s FDA approval of this ANDA clears the regulatory path for a generic entry, positioning the company to compete aggressively against the brand product and erode it…
On July 11, 2013, PH HEALTH received FDA approval for ANDA090734, introducing a new therapeutic option to the market. This clearance is expected to generate significant revenue gro…