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Results For "USFDA-approval"

194 News Found

Medtronic gets USFDA approval of spinal cord stimulation therapy
Medical Device | January 25, 2022

Medtronic gets USFDA approval of spinal cord stimulation therapy

Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone


Strides receives USFDA approval for influenza medicine
Drug Approval | January 17, 2022

Strides receives USFDA approval for influenza medicine

The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval


Alembic receives USFDA approval for Doxycycline Hyclate
Drug Approval | January 04, 2022

Alembic receives USFDA approval for Doxycycline Hyclate

Doxycycline Hyclate Delayed Release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria


Alembic receives tentative USFDA approval for Selexipag tablets
Drug Approval | December 09, 2021

Alembic receives tentative USFDA approval for Selexipag tablets

The tablets are indicated for the treatment of pulmonary arterial hypertension


Zydus gets USFDA approval for arthritis drug
News | August 23, 2021

Zydus gets USFDA approval for arthritis drug

Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength


Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
Drug Approval | August 12, 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol


Caplin gets USFDA approval for Sumatriptan
News | July 15, 2021

Caplin gets USFDA approval for Sumatriptan

Sumatriptan Injection USP is indicated in adults for acute treatment of migraine with or without aura, and acute treatment of cluster headache


Alembic announces USFDA approval for Desipramine Hydrochloride Tablets
News | July 09, 2021

Alembic announces USFDA approval for Desipramine Hydrochloride Tablets

The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA


Zydus Cadila receives USFDA approval for Emtricitabine and Tenofovir Disoproxil
News | July 04, 2021

Zydus Cadila receives USFDA approval for Emtricitabine and Tenofovir Disoproxil

The drug is used with other HIV medications to help control HIV infection and it helps to decrease the amount of HIV in one’s body so that the immune system can work better


Zydus Cadila receives USFDA approval for Fingolimod capsules
News | June 25, 2021

Zydus Cadila receives USFDA approval for Fingolimod capsules

Fingolimod is an immunomodulating drug. It is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis