Drug Approval | December 09, 2021
Alembic receives tentative USFDA approval for Selexipag tablets
The tablets are indicated for the treatment of pulmonary arterial hypertension
The tablets are indicated for the treatment of pulmonary arterial hypertension
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
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)
The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA
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
The injection is used to reverse the effects of the muscle relaxants given to patients during surgery
Metronidazole Gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea
Acetaminophen extended-release tablets 650 mg is bioequivalent of the reference listed drug Tylenol
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
It had an estimated market size of US $ 32 million as of June 2021
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