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
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 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
It had an estimated market size of US $ 32 million as of June 2021
The company has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA
Glenmark has been granted a competitive generic therapy (CGT) designation for theophylline extended-release tablets
Lurasidone Hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA
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