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Hot Stocks
ANI Pharmaceuticals launches Omega-3-Acid Ethyl Esters Capsules USP » 08:37
04/02/20
04/02
08:37
04/02/20
08:37
ANIP

ANI Pharmaceuticals

$38.37 /

-2.66 (-6.48%)

ANI Pharmaceuticals…

ANI Pharmaceuticals announced the launch of Omega-3-Acid Ethyl Esters Capsules USP, 1 gram. The current annual U.S. market for this product is approximately $110M, according to IQVIA/IMS Health.

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Over a week ago
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ANI Pharmaceuticals launches Polyethylene Glycol 3350, 17g/packet » 08:39
03/26/20
03/26
08:39
03/26/20
08:39
ANIP

ANI Pharmaceuticals

$39.99 /

-3.48 (-8.01%)

ANI Pharmaceuticals…

ANI Pharmaceuticals launched Polyethylene Glycol 3350, 17g/Packet. The current annual market for this over the counter product is approximately $21M. This launch represents ANI's fourth new drug introduction in 2020. Polyethylene Glycol 3350 is indicated for the treatment of occasional constipation.

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ANI Pharmaceuticals announces filing of PAS for Purified Cortrophin Gel » 11:03
03/24/20
03/24
11:03
03/24/20
11:03
ANIP

ANI Pharmaceuticals

$39.58 /

+4.51 (+12.86%)

ANI Pharmaceuticals…

ANI Pharmaceuticals announced that it has submitted a prior approval supplement to the Endocrinology Division at the FDA for re-commercialization of Purified Cortrophin Gel. The current annual market for Cortrophin Gel is approximately $950 million and has only one competitor. Cortrophin Gel was originally approved by the FDA in 1954 and last used in patients in the 1980s. Cortrophin Gel has over 54 indications on its previously approved label, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and ulcerative colitis. As part of the PAS, ANI has submitted a comprehensive characterization package which demonstrates an unparalleled understanding of both the API and Cortrophin Gel. The drug has been proven to meet both historical release specifications, as well as modernized release specifications, to ensure compliance with current FDA process validation, method validation and Quality by Design approaches outlined in ICH Guidelines Q8/Q9/Q10. The FDA has a four-month PDUFA requirement to respond to ANI's application and determine whether the Cortrophin Gel PAS submission is complete and acceptable for approval.

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ANI Pharmaceuticals submits PAS to FDA for Purified Cortrophin Gel » 08:32
03/24/20
03/24
08:32
03/24/20
08:32
ANIP

ANI Pharmaceuticals

$35.07 /

-2.08 (-5.60%)

ANI Pharmaceuticals…

ANI Pharmaceuticals announced that it has submitted a prior approval supplement to the Endocrinology Division at the FDA for re-commercialization of Purified Cortrophin Gel. The current annual market for Cortrophin Gel is approximately $950M and has only one competitor. Cortrophin Gel was originally approved by the FDA in 1954 and last used in patients in the 1980s. Cortrophin Gel has over 54 indications on its previously approved label, including but not limited to acute exacerbations of multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and ulcerative colitis.

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Over a month ago
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ANI Pharmaceuticals: FDA approves ANDA for Memantine Hydrochloride capsules » 08:35
03/02/20
03/02
08:35
03/02/20
08:35
ANIP

ANI Pharmaceuticals

$48.01 /

-1.22 (-2.48%)

ANI Pharmaceuticals…

ANI Pharmaceuticals announced that it has received approval of the company's abbreviated new drug application from the U.S. FDA for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg. The current annual U.S. market for this product is approximately $127M, according to IQVIA.

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Earnings
ANI Pharmaceuticals sees 2020 adjusted EPS $4.46-$4.86, consensus $5.47 » 08:33
02/27/20
02/27
08:33
02/27/20
08:33
ANIP

ANI Pharmaceuticals

$59.45 /

+1.58 (+2.73%)

Sees 2020 revenue…

Sees 2020 revenue $213M-$223M, consensus $229.15M.

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Earnings
ANI Pharmaceuticals reports Q4 non-GAAP EPS $1.08, consensus $1.18 » 08:31
02/27/20
02/27
08:31
02/27/20
08:31
ANIP

ANI Pharmaceuticals

$59.45 /

+1.58 (+2.73%)

Reports Q4 revenue…

Reports Q4 revenue $48.0M, consensus $51.63M.

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ANI Pharmaceuticals launches Sulfamethoxazole and Trimethoprim Oral Suspension » 08:32
02/12/20
02/12
08:32
02/12/20
08:32
ANIP

ANI Pharmaceuticals

$65.80 /

-0.19 (-0.29%)

ANI Pharmaceuticals…

ANI Pharmaceuticals launched Sulfamethoxazole and Trimethoprim Oral Suspension USP 200 mg/40 mg per 5 mL. The current annual market for this product is approximately $29M, according to IQVIA. This launch represents ANI's third generic product introduction in 2020. Sulfamethoxazole and Trimethoprim Oral Suspension is indicated in the treatment and prevention of various infections proven or strongly suspected to be caused by susceptible bacteria which include urinary tract infections, acute otitis media, bronchitis, shigellosis, Pneumocystis jiroveci pneumonia, and traveler's diarrhea.

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ANI Pharmaceuticals launches Tolterodine Extended-Release Capsules » 08:31
01/24/20
01/24
08:31
01/24/20
08:31
ANIP

ANI Pharmaceuticals

$61.65 /

-0.31 (-0.50%)

ANI Pharmaceuticals…

ANI Pharmaceuticals announced the launch of Tolterodine Extended-Release Capsules, 2 mg and 4 mg. The current annual U.S. market for this product is approximately $101M, according to IQVIA.

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ANI Pharmaceuticals: FDA approves Potassium Citrate Extended-Release Tablets » 08:32
01/16/20
01/16
08:32
01/16/20
08:32
ANIP

ANI Pharmaceuticals

$59.58 /

+1.55 (+2.67%)

ANI Pharmaceuticals…

ANI Pharmaceuticals announced it has received approval of the company's abbreviated new drug application from the U.S. FDA for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq. The current annual U.S. market for this product is approximately $75M, according to IQVIA.

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