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87 News Found

Alembic receives tentative U.S.FDA approval for dronedarone tablets
Drug Approval | January 10, 2022

Alembic receives tentative U.S.FDA approval for dronedarone tablets

Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA


U.S. FDA grants approval for Alembic’s Parkinson’s drug
Drug Approval | January 06, 2022

U.S. FDA grants approval for Alembic’s Parkinson’s drug

Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA


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


Granules receives ANDA approval for amphetamine mixed salts
Drug Approval | December 30, 2021

Granules receives ANDA approval for amphetamine mixed salts

The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health


Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


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


U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution
Drug Approval | November 23, 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies


Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules
Drug Approval | November 23, 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)


Alembic JV receives final approval for Mupirocin cream
Drug Approval | November 17, 2021

Alembic JV receives final approval for Mupirocin cream

The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA


Granules gets ANDA approval for Dofetilide capsules
Drug Approval | October 18, 2021

Granules gets ANDA approval for Dofetilide capsules

The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm