Alembic Pharmaceuticals receives USFDA Tentative Approval for Palbociclib Capsules, 75 mg, 100 mg, and 125 mg

Alembic Pharmaceuticals Limited today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Palbociclib Capsules, 75 mg, 100 mg, and 125 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), lbrance Capsules, 75 mg, 100 mg, and 125 mg, of Pfizer Inc. (Pfizer). Palbociclib Capsule is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or in combination with fulvestrant in women with disease progression following endocrine therapy.

Palbociclib Capsules, 75 mg, 100 mg, and 125 mg have an estimated market size of US$ 624 million for twelve months ending Jun 2020 according to IQVIA. Alembic is currently in litigation with Pfizer in District Court of Delaware and launch of the product will depend on litigation outcome.

Alembic now has a total of 135 ANDA approvals (117 final approvals and 18 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.977 as compared to the previous close of Rs. 992.8. The total number of shares traded during the day was 55599 in over 499 trades.

The stock hit an intraday high of Rs. 993.9 and intraday low of 976.1. The net turnover during the day was Rs. 54703391.

Source : Equity Bulls

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