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Blog Exposure - FDA Granted Final Approval to a Generic Version of Perrigo’s Estrace Cream

LONDON, UK / ACCESSWIRE / January 26, 2018 / Active-Investors.com has just released a free research report on Perrigo Co. PLC (NYSE: PRGO). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=PRGO as the Company's latest news hit the wire. On January 24, 2018, the Company declared that it has received final approval from the US Food and Drug Administration (FDA) for the generic version of Estrace® Cream (estradiol vaginal cream, USP, 0.01%). This product will be marketed by Perrigo's partner, Impax Laboratories, Inc. (NASDAQ: IPXL), and is expected to launch in Q2 2018. Register today and get access to over 1,000 Free Research Reports by joining our site below:


Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Perrigo and Impax Labs most recent news is on our radar and our team decided to put out fantastic reports on these two companies that are now available for free below:



FDA's Approved Launch of AB Rated Generic Version of Epiduo® Gel

On the same day, Perrigo received a final approval from the FDA and it launched an AB rated generic version of Epiduo® (adapalene and benzoyl peroxide) Gel - 0.1%/2.5%. Epiduo® Gel is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. On January 03, 2018, FDA granted tentative approval for the generic version of Prolensa® (bromfenac ophthalmic solution) 0.07%. the Company previously settled litigation with Bausch & Lomb Inc. for this product.

Approvals Received by FDA in 2017

In November 2017, FDA provided tentative approval to the generic version of Picato® Gel 0.05%, indicated for the topical treatment of actinic keratosis. Perrigo received tentative approval from FDA for the generic version of Picato® Gel 0.015% in October 2017.

Perrigo received final approvals from FDA for its AB rated Abbreviated New Drug Application (NDA) referencing Exalgo® - 32mg extended release tablets (hydromorphone HCl), and tentative approval for the generic version of Acanya® topical gel 1.2%/2.5% in September 2017.

In August 2017, FDA granted final approvals to store brand OTC equivalent of Nexium® 24HR capsules, AB rated Abbreviated NDA referencing Mycolog® II Cream (nystatin and triamcinolone acetonide cream USP, 100,000 units/gram and 1 mg/gram). In the same month, FDA provided tentative approval to generic version of Mirvaso® topical gel 0.33%.

In July 2017, Perrigo's AB rated Abbreviated NDA referencing DermOtic® Oil, 0.01% Ear Drops (fluocinolone acetonide oil 0.01%) and AbbVie Inc.'s Androgel® Topical Gel - 1.62% packets (20.25 mg/1.25 g packet and 40.5 mg/2.5 g packet) received FDA's final approvals. In March 2017, the Company's Abbreviated NDA referencing Eli Lilly and Co.'s Axiron® Topical Solution - 30 mg/1.5 mL was approved.

FDA granted final approval to Perrigo's first-to-file Abbreviated NDA referencing Taro Pharmaceuticals USA Inc.'s Topicort® Spray (desoximetasone topical spray, 0.25%) and hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) - 5 mg/1.5 mg per 5 mL, in January and February 2017 respectively.

About Estrace® Cream

Estrace® Cream is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. According to IMS Health, market sales of Estrace® Cream over the last 12 months were approximately $457 million.

About Perrigo Co. PLC

Founded in 1887 and headquartered in Dublin, Ireland, Perrigo is a leading global healthcare company that delivers value to its customers and consumers by providing Quality Affordable Healthcare Products. The Company is the world's largest manufacturer of over-the-counter (OTC) healthcare products and supplier of infant formulas for the store brand market.

Stock Performance Snapshot

January 25, 2018 - At Thursday's closing bell, Perrigo's stock rose 1.05%, ending the trading session at $94.59.

Volume traded for the day: 689.41 thousand shares.

Stock performance in the last month – up 8.71%; previous three-month period – up 9.91%; past twelve-month period – up 29.93%; and year-to-date - up 8.52%

After yesterday's close, Perrigo's market cap was at $13.29 billion.

The stock has a dividend yield of 0.68%.

The stock is part of the Healthcare sector, categorized under the Drug Related Products industry. This sector was up 0.9% at the end of the session.


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