Financial News Archive

SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s

Lupin
FDA Approves MORPHINE SULFATE — Lupin Pharmaceuticals,Inc.

Lupin Pharmaceuticals, Inc. announced that the FDA approved its Abbreviated New Drug Application (ANDA) for Morphine Sulfate Oral Solution, offering a...

Aurobindo
FDA Approves RISEDRONATE SODIUM — Aurobindo Pharma Limited

Aurobindo Pharma received FDA approval for its generic Risedronate Sodium oral tablets, opening a new revenue opportunity within the osteoporosis mark...

BioDelivery
FDA Approves BELBUCA — BioDelivery Sciences International Inc

BioDelivery Sciences International Inc. announced the FDA approval of BELBUCA, a buccal film intended for the management of moderate to severe chronic...

WG
FDA Approves DEXMEDETOMIDINE — WG Critical Care, LLC

# FDA Approves WG Critical Care's Dexmedetomidine Injection for Intravenous Use WG Critical Care, LLC has received FDA approval for its intravenous d...

Apotex
FDA Approves IBANDRONATE SODIUM — Apotex Corp.

# FDA Approves Apotex's Generic Ibandronate Sodium Injection Apotex Corp. received FDA approval for its generic ibandronate sodium intravenous formul...

Aurolife
FDA Approves METHADONE HYDROCHLORIDE — Aurolife Pharma, LLC

# FDA Approves Aurolife Pharma's Generic Methadone Hydrochloride Aurolife Pharma, LLC has received FDA approval for its generic methadone hydrochlori...

Boehringer
FDA Approves SYNJARDY — Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc. announced the FDA approval of SYNJARDY (empagliflozin and metformin hydrochloride tablets), combining two w...

Epic
FDA Approves METHADONE HYDROCHLORIDE — Epic Pharma, LLC

On August 18, 2015, Epic Pharma, LLC received approval for ANDA090065 to manufacture generic methadone hydrochloride tablets, a move expected to inten...

Vertex
FDA Approves ORKAMBI — Vertex Pharmaceuticals Incorporated

# FDA Approves Vertex Pharmaceuticals' ORKAMBI for Cystic Fibrosis Vertex Pharmaceuticals Incorporated received FDA approval for ORKAMBI (lumacaftor ...

PHARMOBEDIENT
FDA Approves Unknown Drug — PHARMOBEDIENT

Pfizer Inc. has received approval for key filings related to its ANDA206456, filling a pivotal gap in the U.S. generic market for EchoPharm's branded ...

Saptalis
FDA Approves DESOXIMETASONE — Saptalis Pharmaceuticals, LLC.

# FDA Approves Saptalis Pharmaceuticals' Generic Desoximetasone Topical Treatment Saptalis Pharmaceuticals, LLC has received FDA approval for its gen...

Advagen
FDA Approves BUPRENORPHINE HYDROCHLORIDE — Advagen Pharma Ltd

Advagen Pharma Ltd has received FDA approval for its Abbreviated New Drug Application (ANDA090279) to market buprenorphine hydrochloride tablets for s...

Xiromed
FDA Approves JAIMIESS — Xiromed LLC

Xiromed LLC secured FDA approval for JAIMIESS, the generic version of Levonorgestrel and Ethinyl Estradiol tablets, positioning the company to capture...

Cranbury
FDA Approves MORPHINE SULFATE — Cranbury Pharmaceuticals, LLC

Cranbury Pharmaceuticals, LLC secured FDA approval for its generic Morphine Sulfate oral formulation, granting the company a strategic foothold in the...

Lupin
FDA Approves OXYCODONE HYDROCHLORIDE — Lupin Pharmaceuticals, Inc.

Lupin Pharmaceuticals, Inc. received FDA approval for its Abbreviated New Drug Application #ANDA204603 to manufacture Oxycodone Hydrochloride on April...

ACTAVIS
FDA Approves Unknown Drug — ACTAVIS ELIZABETH

Sanofi has announced that its subsidiary, Actavis Elizabeth, has received final approval from the FDA for its generic drug, which is expected to竞争扩大该产...

Novartis
FDA Approves COSENTYX — Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals received FDA approval for Secukinumab (Cosentyx) on Jan. 21, 2015, a strategic milestone expected to bolster the company’s po...

Zydus
FDA Approves CARBIDOPA AND LEVODOPA — Zydus Pharmaceuticals USA Inc.

Zydus Pharmaceuticals USA Inc. secured FDA approval for Carbidopa and Levodopa, providing a new oral generic option into the high-volume central nervo...

TEVA
FDA Approves Unknown Drug — TEVA PHARMS USA

Teva Pharmaceutical received FDA approval for its Abbreviated New Drug Application (ANDA 202718) on December 29, 2014, enabling the generic launch of ...

E.R.
FDA Approves OPDIVO — E.R. Squibb & Sons, L.L.C.

The FDA has approved Opdivo (nivolumab) from E.R. Squibb & Sons, L.L.C., a key asset for the manufacturer's oncology franchise that is poised to bolst...