Drug Approval | May 11, 2022
Alembic Pharmaceuticals receives USFDA approval for Arformoterol Tartrate
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The US business faced price erosion due to increased competition.
Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
Juneja brings more than three decades of experience in pharmaceutical sales and marketing
Pharma veteran with over three decades of industry experience to lead Alembic’s animal health growth and market expansion initiatives.
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