Multiple Sclerosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-11-03FDA Approved: PLEGRIDY PEN — Supplemental Application (Biogen Inc.)
FDA approved a supplemental application for the Plegridy Pen auto-injector for peginterferon beta-1a, submitted by Biogen. The action approv…
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FDA approval · 2021-10-28FDA Approved: PONVORY — Supplemental Application (Janssen Pharmaceuticals, Inc)
FDA approved Janssen's supplemental application for PONVORY (ponesimod), authorizing changes to its labeling.
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FDA approval · 2021-09-29FDA Approved: DALFAMPRIDINE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for dalfampridine from Aurobindo Pharma Limited.
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FDA approval · 2021-09-22FDA Approved: BACLOFEN — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for baclofen from Chartwell RX, LLC, under ANDA077241, indicating regulatory approval of this supple…
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FDA approval · 2021-09-15FDA Approved: DALFAMPRIDINE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories, LLC's supplemental application for dalfampridine, resulting in a generic dalfampridine product being appro…
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FDA approval · 2021-09-15FDA Approved: DALFAMPRIDINE — Supplemental Application (Micro Labs Limited)
The FDA approved a supplemental application for dalfampridine from Micro Labs Limited (ANDA210158), enabling a generic version to be markete…
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FDA approval · 2021-09-10FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Mayzent (siponimod) by Novartis Pharmaceuticals Corporation.
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FDA approval · 2021-09-08FDA Approved: DALFAMPRIDINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA has approved a supplemental application for dalfampridine from Sun Pharmaceutical Industries, Inc. This approval updates the regulat…
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FDA approval · 2021-09-08FDA Approved: DALFAMPRIDINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for dalfampridine from Actavis Pharma, Inc., resulting in the approval of a generic dalfampridine pr…
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FDA approval · 2021-08-24FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for Mayzent (siponimod) filed by Novartis Pharmaceuticals Corporation. The action updates the dr…
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FDA approval · 2021-07-13FDA Approved: BACLOFEN — Original Application (Medcore LLC)
FDA approves Medcore LLC's original ANDA for generic baclofen (oral) for the treatment of spasticity associated with multiple sclerosis and …
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FDA approval · 2021-04-30FDA Approved: BACLOFEN — Supplemental Application (Method Pharmaceuticals LLC)
The FDA approved a supplemental application for Baclofen submitted by Method Pharmaceuticals LLC under ANDA212378. This action approves a su…
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FDA approval · 2021-04-30FDA Approved: AUBAGIO — Supplemental Application (Genzyme Corporation)
The FDA approved a supplemental application for Aubagio (teriflunomide) by Genzyme Corporation. The submission status is AP.
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FDA approval · 2021-04-23FDA Approved: TERIFLUNOMIDE — Supplemental Application (MSN LABORATORIES PRIVATE LIMITED)
FDA approved a supplemental application for teriflunomide from MSN Laboratories Private Limited, enabling the marketing of a generic version…
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FDA approval · 2021-04-07FDA Approved: TERIFLUNOMIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a generic teriflunomide from Aurobindo Pharma Limited.
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FDA approval · 2021-03-29FDA Approved: TERIFLUNOMIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for teriflunomide from Mylan Pharmaceuticals Inc., indicating an approved update to the product prev…
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FDA approval · 2021-03-26FDA Approved: DIMETHYL FUMARATE — Original Application (SOLA Pharmaceuticals, LLC)
The FDA approved SOLA Pharmaceuticals, LLC's Original Application for dimethyl fumarate, a generic version indicated for relapsing forms of …
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FDA approval · 2021-03-18FDA Approved: PONVORY — Original Application (Janssen Pharmaceuticals, Inc)
FDA approves PONVORY (ponesimod) from Janssen as the original approval for treatment of adults with relapsing forms of multiple sclerosis.
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FDA approval · 2021-03-05FDA Approved: FINGOLIMOD — Original Application (Dr. Reddy's Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' generic fingolimod under an Original Application, making a generic version of fingolimod available fo…
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FDA approval · 2021-03-05FDA Approved: BACLOFEN — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for a generic baclofen (oral) by Rising Pharma Holdings, Inc. The approval covers use for management o…
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FDA approval · 2021-02-24FDA Approved: AMPYRA — Supplemental Application (Merz Pharmaceuticals, LLC)
FDA approved a Supplemental Application for AMPYRA (dalfampridine) submitted by Merz Pharmaceuticals, LLC.
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FDA approval · 2021-02-09FDA Approved: FINGOLIMOD — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for fingolimod submitted by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2021-01-29FDA Approved: VUMERITY — Supplemental Application (Biogen Inc.)
FDA approved a supplemental application for Biogen's VUMERITY (diroximel fumarate). The approval updates the product's labeling to reflect t…
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FDA approval · 2021-01-29FDA Approved: PLEGRIDY PEN — Supplemental Application (Biogen Inc.)
The FDA approved Biogen's supplemental application for the PLEGRIDY PEN (peginterferon beta-1a), a pen-delivery device for administering peg…
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FDA approval · 2021-01-23FDA Approved: MAYZENT — Supplemental Application (Novartis Pharmaceuticals Corporation)
The FDA approved a supplemental application for MAYZENT (siponimod) from Novartis Pharmaceuticals Corporation. The approval updates the prod…